MAUDE Adverse Event Report: HOLGER ULLRICH UNIVERSAL FRAME, EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 100724A1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Nerve Damage (1979)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

The following was reported.A patient was undergoing a back surgery.For this surgery the adjustable body supports 100728b0 were used on the universal frame, eu 100724a1.On recovering from anesthesia the patient experienced severe weakness of the right upper limb.Clinical evaluation revealed grade 0 motor power of all the muscle groups of the right upper limb.A brachial plexus injury was diagnosed.Manufacturer reference# (b)(4).

Manufacturer Narrative

No product failure is apparent which caused the described injury.We have not received any complaints before or after this incident concerning the affected products.We have not received any further information concerning similar incidents from the affected clinic.We assume that the intraoperative positioning of the arms combined with an extended duration of the surgery might have contributed to the described injury.In the instructions for use (ifu) the user is warned concerning the risks related to patient positioning as follows: ¿warning! risk of injury! improper patient positioning may cause health damage (e.G.Decubitus).Position the patient correctly and keep under constant observation.¿ the correct application and positioning of the pads is described in the ifu.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference# (b)(4).

• Brand Name: UNIVERSAL FRAME, EU
• 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: 10566546
• MDR Text Key: 207913931
• Report Number: 8010652-2020-00019
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100724A1
• Device Catalogue Number: 100724A1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100728B0 ADJUSTABLE BODY SUPPORTS; 100728B0 ADJUSTABLE BODY SUPPORTS
• Patient Outcome(s): Other