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 Type  malfunction  

Event Description

It was reported that the support arm broke.There was no patient harm.Manufacturer's ref: (b)(4).

Event Description

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

Manufacturer Narrative

No service/repair was requested.No parts were returned.The broken support arm was discarded by the user facility.Investigation was based on picture received showing that the support arm had fallen apart at the joint nearest to the bracket.The cause of the support arm failure 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: 8943872
• MDR Text Key: 155961664
• Report Number: 8010042-2019-00632
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• 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: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1