MAUDE Adverse Event Report: MAQUET GMBH IR REMOTE CONTROL; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 116091A0

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(4) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.

Manufacturer Narrative

On (b)(6) 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(4) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Based on available information, the malfunction could not be reproduced.The affected remote control was returned to the manufacturing site for investigation.Signs of use and scratches were found on the remote control, but no major damage.A functional test was performed and no malfunction of the remote control could be detected.The affected table was investigated by a service technician on site and is said to be working fine.No damages and no malfunction were found on the table.The error logs of the table were investigated and no hints pointing towards the described malfunction were found.No product malfunction could be found on the table or remote control.The user stated that no other kind of remote control (e.G.Food switch, cable remote control) was in use when this incident occurred.We cannot determine the root cause of this issue.It cannot be excluded that the or table was accidentally operated from the immediate vicinity of the or or by accidentally activating a button on the remote control or the override control panel on the column or another remote device.An operating table can only be operated with the ir remote control that was uniquely assigned to the or table.This assignment is done by setting the ir code on the remote control that is matching the tables ir code.In the ifu it is described how the ir code can be set on the ir remote control.It cannot be determined whether the device was up to the manufacturer¿s specifications when the issues occurred.The provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, 116091a0 - ir remote control was directly involved with the reported incident.There was one complaint related to the similar issue.Comparing the number of complained devices (2) to the number of units placed on the market up to the end of august 2020 (4224) we can conclude the failure ratio is 0,05% for the investigated issue.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2020) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.

Event Description

On 7th january 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(6) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.

Manufacturer Narrative

The correction of b5 describe event or problem and h10 additional manufacturer narrative fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 27th august 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(6) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Corrected b5 describe event or problem: on 7th january 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(6) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Previous h10 additional manufacturer narrative: on 27th august 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# 771 with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Based on available information, the malfunction could not be reproduced.The affected remote control was returned to the manufacturing site for investigation.Signs of use and scratches were found on the remote control, but no major damage.A functional test was performed and no malfunction of the remote control could be detected.The affected table was investigated by a service technician on site and is said to be working fine.No damages and no malfunction were found on the table.The error logs of the table were investigated and no hints pointing towards the described malfunction were found.No product malfunction could be found on the table or remote control.The user stated that no other kind of remote control (e.G.Food switch, cable remote control) was in use when this incident occurred.We cannot determine the root cause of this issue.It cannot be excluded that the or table was accidentally operated from the immediate vicinity of the or or by accidentally activating a button on the remote control or the override control panel on the column or another remote device.An operating table can only be operated with the ir remote control that was uniquely assigned to the or table.This assignment is done by setting the ir code on the remote control that is matching the tables ir code.In the ifu it is described how the ir code can be set on the ir remote control.It cannot be determined whether the device was up to the manufacturer¿s specifications when the issues occurred.The provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, 116091a0 - ir remote control was directly involved with the reported incident.There was one complaint related to the similar issue.Comparing the number of complained devices (2) to the number of units placed on the market up to the end of august 2020 (4224) we can conclude the failure ratio is (b)(4)% for the investigated issue.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2020) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.Corrected h10 additional manufacturer narrative: on 7th january 2020, getinge became aware of an issue with one of our remote controls - 116091a0 - ir remote control.The customer reported the following.The customer operated the or table 116001c0, serial# (b)(6) with the ir remote control.According to the customer: afterwards the remote control was put onto an anesthesia machine.The customer reported that the table moved to trendelenburg position without any function being operated on the remote control.The patient fell off the table.The originally planned intervention could not be performed.A ct scan was performed on the patient.No injury was visible in this scan and no other injury of the patient was reported.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Based on available information, the malfunction could not be reproduced.The affected remote control was returned to the manufacturing site for investigation.Signs of use and scratches were found on the remote control, but no major damage.A functional test was performed and no malfunction of the remote control could be detected.The affected table was investigated by a service technician on site and is said to be working fine.No damages and no malfunction were found on the table.The error logs of the table were investigated and no hints pointing towards the described malfunction were found.No product malfunction could be found on the table or remote control.The user stated that no other kind of remote control (e.G.Food switch, cable remote control) was in use when this incident occurred.We cannot determine the root cause of this issue.It cannot be excluded that the or table was accidentally operated from the immediate vicinity of the or or by accidentally activating a button on the remote control or the override control panel on the column or another remote device.An operating table can only be operated with the ir remote control that was uniquely assigned to the or table.This assignment is done by setting the ir code on the remote control that is matching the tables ir code.In the ifu it is described how the ir code can be set on the ir remote control.It cannot be determined whether the device was up to the manufacturer¿s specifications when the issues occurred.The provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, 116091a0 - ir remote control was directly involved with the reported incident.There was one complaint related to the similar issue.Comparing the number of complained devices (2) to the number of units placed on the market up to the end of august 2020 (4224) we can conclude the failure ratio is 0,05% for the investigated issue.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2020) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.

• Brand Name: IR REMOTE CONTROL
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 15231852
• MDR Text Key: 305363617
• Report Number: 8010652-2022-00016
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 116091A0
• Device Catalogue Number: 116091A0
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 116001C0 - OTESUS OR TABLE COLUMN, MOBILE.