MAUDE Adverse Event Report: MAQUET GMBH UNIVERSAL TABLE TOP, IPC, EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116010A0

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.The full event site name is: (b)(6).

Event Description

The following was reported to us.During positioning of an anesthetized patient for the gynecological surgery, the upper leg plates (113373bc) collided with arm protection (100225a0) on both sides.The table top was changed for the damage evaluation which resulted in 30 minutes of delay.There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.

Manufacturer Narrative

Getinge became aware of an issue with 116010a0 universal table top.It was stated that during positioning of an anesthetized patient for the gynecological surgery, the upper leg plates (113373bc) collided with arm protection (100225a0) on both sides.The table top was changed for damage evaluation which resulted in 30 minutes of delay.We decided to report the issue due to major delay (about 30 minutes).There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.Based on information provided by getinge technician, broken leg plates were replaced.It was established that when the event occurred, the universal table top met its specification.Provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, the universal table top, arm protection and leg plates were directly involved with the reported incident.There were no similar reportable complaints related to this issue.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio is very low.Following evaluation by subject matter expert, the arm protection (100225a0) has been set too close to the leg side of the universal table top.The root cause for this issue is user error.In instruction for use for 116010a0 universal table top (ifu116010xyen05, page 21) the user is warned that during adjustments the table top and accessories needs to be constantly observed to avoid collision.The user was informed about root cause of this issue.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.The correction of d3 manufacturer and d4 version or model # fields deems required.This is based on the internal evaluation.Previous d3 manufacturer holger ullrich corrected d3 manufacturer maquet gmbh previous d4 version or model # 116010a0 - universal table top, ipc, eu corrected d4 version or model # 116010a0.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: UNIVERSAL TABLE TOP, IPC, EU
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 14083904
• MDR Text Key: 289954082
• Report Number: 8010652-2022-00002
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116010A0
• Device Catalogue Number: 116010A0
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2022
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 113373BC LEG PLATES, 100225A0 ARM PROTECTION
• Patient Sex: Prefer Not To Disclose