MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM

Model Number SUPPORT ARM 177

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer did not request service, and replaced the broken support arm by themselves.No pictures or parts were received for further investigation the support arm is a casting, and it most probably developed a crack at an earlier occasion either by overloading, or impact, and this led to the reported breaking.Previous investigations led to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.This change was implemented in production during september 2009.However, since no pictures, or parts provided for our investigation, the root cause of the broken support can not be established.

Event Description

It was reported that the support arm of the ventilator was damaged.There was no patient harm.Manufacturer ref.#: (b)(4).

• Brand Name: SUPPORT ARM 177
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: roentgenvagen 2; solna
• MDR Report Key: 10800219
• MDR Text Key: 215049177
• Report Number: 8010042-2020-00919
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 177
• Device Catalogue Number: 6481720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1