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 Patient Involvement (2645)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

It was reported that the support arm fixing plate got detached.There was no patient involvement.Manufacturer's ref.#: (b)(4).

Event Description

Manufacturer ref#: (b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer on-site.The support arm was identified defective.The part was returned to manufacturer for technical investigation and issue was confirmed.The cause of the reported component failure has not been established in this investigation.

• 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: 10761769
• MDR Text Key: 213921075
• Report Number: 8010042-2020-00880
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1