MAUDE Adverse Event Report: HOLGER ULLRICH MEERA EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B2

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Crushing Injury (1797); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)

Event Date 04/04/2021

Event Type  Injury  

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected table and has not found any damage or malfunction.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.

Event Description

The following was reported.The patient was on the table when the table was lowered as requested.The customer described that the table "jolted" and a part of the tables base fell on the left foot of a surgeon.This caused an injury.We have requested further information concerning the incident and the extent of the injury, but not received it yet.Manufacturer reference# (b)(4).

Event Description

The clinic stated that the table was driven into the trendelenburg position when the issue occurred.An x-ray was taken of the injured foot.No broken bones were found due to this accident.The surgeon got some painkiller.No mayor delay of the surgery has occurred.Manufacturer reference# (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected table and has not found any damage or malfunction.Further information concerning this incident was requested from the clinic, but not provided.We assume that the following has happened.The tables' downward movement was blocked by an obstacle, e.G.An instrument table.When the table or a part of it was moved downwards, the tables base was lifted of the floor.Once the obstacle broke or slipped out, the tables base was lowered back on the floor and crushed the doctors foot.In the instructions for use (ifu) it is stated the user has to pay attention and avoid collisions when operating the table.In chapter 2 of the ifu possible hazards are stated: "warning! risk of injury! when adjusting and moving the or table, the table top or the accessories, collisions may occur with the patient, between the individual products or parts pointing downwards.During the adjustment procedures, always pay attention to the or table and accessories and avoid collisions.Ensure that tubes, cables and drapes are not trapped." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MEERA EU WITH AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 11655697
• MDR Text Key: 247909974
• Report Number: 3013876692-2021-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2021
• Distributor Facility Aware Date: 09/28/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other