MAUDE Adverse Event Report: MAQUET GMBH UNIVERSAL REMOTE DEVICE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number	100925A0
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).Device not returned to manufacturer.
Event or Problem Description
On 30th march 2023 getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control.During gynecological procedure, while the staff tried to lift the patient's leg via remote control, touchscreen of the remote control stopped working.The staff connected cord to the handcontrol, however, it did not resolve the issue and different handcontrol was brought from another operating room.The issue led to a short delay.There was no injury 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.
Additional Manufacturer Narrative
Getinge became aware of an issue with 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected the cord to the hand control, however, it did not resolve the issue and a different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.There was no injury 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 remote control was returned to the manufacturing site for further evaluation.The visual inspection of the remote control revealed a crack as well as an impact point, which was documented within the inspection report by photographic evidence.Due to the display not responding to touch, the functional test was not possible.The assessment of the process assurance team pointed out that the device was handled improperly ¿ the impact points and crack were probably caused by a collision, impact or fall.As it was provided, the electronics inside the remote control are very sensitive, which can lead to problems with the electronics due to the force of the damage.Further investigation by the supplier was deemed not needed due to the mechanical damage concluded.In the user manual (ifu 1009.25 en 04, page 65) the user is warned that there is a risk of property damages caused as a result of collision when moving/adjusting the mobile operating table.The user is instructed to remove potential hindrances before moving/adjusting the mobile operating table and avoid collisions.The user is also warned that the remote control attached to the side rail can slip off the side rail when the table top is adjusted or cause collisions with the or table or other accessories.The user should remove the control device from the side rail before adjusting the table top (ifu 1009.25 en 04, page 69).Further, the user is instructed that to ensure correct operation, it is necessary to have visual and functional inspections performed by a trained person prior to each use (ifu 1009.25 en 04, page 76) and that the damaged product may not be used (ifu 1009.25 en 04, page 81).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 remote control was defective, it was considered that the getinge device was not up to specification.The root cause for the reported issue is a user error related to the improper handling of the remote control.In the past there were two additional similar customer product complaints related to the same scenario as investigated here, therefore the failure ratio is 0,07% for the issue investigated herein regarding the universal remote control.The failure ratio for the configuration of the remote control and universal table top is 0,05%.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 h3a device evaluated by manufacturer, h3b device not eval provide code and h3c if other provide code - explain fields deems required.Previous h3a device evaluated by manufacturer: no corrected h3a device evaluated by manufacturer: yes previous h3b device not eval provide code: other corrected h3b device not eval provide code: n/a previous h3c if other provide code - explain: device not returned to manufacturer corrected h3c if other provide code - explain: n/a.
Event or Problem Description
On 30th march 2023, getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected cord to the hand control, however, it did not resolve the issue.The different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.There was no injury 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.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected cord to the hand control, however, it did not resolve the issue.The different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.It was established that the device failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.The manufacturer initiated capa 2024-001.The correction of b5 describe event or problem, d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h6 investigation findings, h6 component codes and h6 investigation conclusions fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 30th march 2023, getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected cord to the hand control, however, it did not resolve the issue.The different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.There was no injury 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 30th march 2023, getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected cord to the hand control, however, it did not resolve the issue.The different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.Previous d1 brand name: universal remote control.Corrected d1 brand name: universal remote device.Previous d4 catalog #: 100925a0.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h6 investigation findings: mechanical problem identified|stress problem identified|mechanical shock problem|3217.Corrected h6 investigation findings: electrical problem identified|electrical/electronic component problem identified||4203.Manufacturing process problem identified|assembly problem identified||706.Previous h6 component codes: electrical and magnetic|transmitter||3141.Electrical and magnetic|user input device|touchscreen|4764.Corrected h6 component codes: mechanical|connector/coupler||4733.Mechanical|controller||765.Previous h6 investigation conclusions: cause traced to user||19.Corrected h6 investigation conclusions: cause traced to manufacturing||25.
Event or Problem Description
On 30th march 2023, getinge became aware of an issue with one of our accessories ¿ 100925a0 - universal remote control used with 116010a0 universal table top, ipc, eu.During the gynecological procedure, while the staff tried to lift the patient's leg via the remote control, the touchscreen of the remote control stopped working.The staff connected cord to the hand control, however, it did not resolve the issue.The different hand control was brought from another operating room.The issue led to a short delay of approximately 15 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.

• Brand Name: UNIVERSAL REMOTE DEVICE
• Common Device Name: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, 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: 16680409
• Report Number: 8010652-2023-00032
• Device Sequence Number: 7387658
• Product Code: JEA
• UDI-Device Identifier: 04046768134294
• UDI-Public: (01)04046768134294(11)210112
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: 100925A0
• Device Catalogue Number: 100925A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 10/22/2024
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/01/2023; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 116010A0 - UNIVERSAL TABLE TOP, IPC, EU.
• Patient Sex: Unknown