MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 176; SUPPORT, ARM

Model Number SUPPORT ARM 176

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The support arm was investigated by our field service engineer and was repaired by mounting new screws.The root cause of the broken support arm has not been conclusively determined but most likely has it been exposed to a mechanical force greater than it is designed to sustain.

Event Description

It was reported that the support arm broke at the lower end.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

• Brand Name: SUPPORT ARM 176
• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11357104
• MDR Text Key: 240649376
• Report Number: 8010042-2021-00436
• 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
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 176
• Device Catalogue Number: 6405976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2015
• 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