MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 179; SUPPORT, ARM

Model Number SUPPORT ARM 179

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2022

Event Type  malfunction  

Manufacturer Narrative

The support arm was investigated by our distributor on-site and was identified defective.The support arm was not returned to manufacturer for technical investigation.The cause of the reported component failure has not been established.

Event Description

It was reported that the fixing bracket of the support arm failed and could not be fixed.There was no patient harm.Manufacturer's ref #: (b)(4).

• Brand Name: SUPPORT ARM 179
• 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16460492
• MDR Text Key: 310442517
• Report Number: 8010042-2023-00447
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 179
• Device Catalogue Number: 6882001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose