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

Model Number SUPPORT ARM 179

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that the angle adjustment handle of the support arm comes off.There was no patient involvement.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The ventilator was was investigated by our field service engineer on-site.The support arm was identified defective.No part has been returned to manufacturer for technical investigation.The cause of the reported component failure has not been established in this investigation.

Event Description

Manufacturer 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: 12088426
• MDR Text Key: 259272936
• Report Number: 8010042-2021-01547
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose