MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 178; SUPPORT, ARM

Model Number SUPPORT ARM 178

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Event Description

It was reported that the support arm for patient tubes, mounted on the ventilator carrier, broke.There was no patient harm.(b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The support arm was not returned for investigation.According to provided pictures and additional information, the ball bearings on the rail clamp mounted on the support arm were stuck.This has most likely contributed to an inability to fasten the support arm on the side rail mounted on the ventilator carrier.The root cause of the stuck ball bearings has not been determined.

• Brand Name: SUPPORT ARM 178
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9223759
• MDR Text Key: 174327671
• Report Number: 8010042-2019-00776
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 178
• Device Catalogue Number: 6693715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1