MAUDE Adverse Event Report: MAQUET GMBH BASIS TABLE TOP,INDIVIDUAL CONFIGURATION; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118010F0

Device Problems Communication or Transmission Problem (2896); Positioning Problem (3009); Insufficient Information (3190)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 20th july 2022 getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top,individual configuration.As it was stated, due to an unspecified table malfunction, anesthetized patient required transfer to another operating room which resulted in a delay of approximately 45 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem and h6 medical device ¿ problem code fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 20th july 2022 getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top,individual configuration.As it was stated, due to an unspecified table malfunction, anesthetized patient required transfer to another operating room which resulted in a delay of approximately 45 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.Previous h6 medical device ¿ problem code: insufficient information|||3190.Corrected h6 medical device ¿ problem code: activation, positioning or separation problem|positioning problem||3009.

Event Description

On 20th july 2022 getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top,individual configuration.As it was stated, table could not be moved in height leading to transfer of anesthetized patient to another operating room which resulted in a delay of approximately 45 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

On 20th july 2022, getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top, individual configuration used with hybrid or table column.As it was stated, during usage with the patient the table could not be moved up leading to the transfer of the anesthetized patient to another operating room, which resulted in a delay of approximately 45 minutes.When the described situation occurred, the incision was not yet made.Fortunately, there was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Manufacturer Narrative

Getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top, individual configuration used with hybrid or table column.As it was stated, the table could not be moved in height leading to the transfer of the anesthetized patient to another operating room, which resulted in a delay of approximately 45 minutes.The incision was not yet made when the issue occurred.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device was evaluated by the company¿s technician.The technician was able to reestablish the communication between the getinge device and the philips angiography device by rebooting the philips device.The technician logged into the table and no hard errors were found.It is possible that the reported malfunction was caused by the philips device malfunction as the communication issue was solved by rebooting this device.No malfunction related to the communication issue was found for the getinge device.The root cause for the reported issue is impossible to define.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As the communication issue between the getinge device and philips angiography system was found, it was considered that the getinge device was not up to specification.There were two similar complaints found related to this issue failure pattern as described in this event, therefore the failure ratio for the configuration of the devices is (b)(4) for the issue investigated herein.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 20th july 2022 getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top,individual configuration.As it was stated, table could not be moved in height leading to transfer of anesthetized patient to another operating room which resulted in a delay of approximately 45 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.Corrected b5 describe event or problem: on 20th july 2022, getinge became aware of an issue with one of our table tops ¿ 118010f0 - basis table top, individual configuration used with hybrid or table column.As it was stated, during usage with the patient the table could not be moved up leading to the transfer of the anesthetized patient to another operating room, which resulted in a delay of approximately 45 minutes.When the described situation occurred, the incision was not yet made.Fortunately, there was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

• Brand Name: BASIS TABLE TOP,INDIVIDUAL CONFIGURATION
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• 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: 15189758
• MDR Text Key: 305055186
• Report Number: 8010652-2022-00013
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118010F0
• Device Catalogue Number: 118010F0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1