MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 178; BED, FLOTATION THERAPY, POWERED

Catalog Number 6481720

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

It was reported that the support arm of the ventilator was damaged.Patient involvement was unknown.(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.No part has been returned to manufacturer for technical investigation.The cause of the reported component failure has not been established in this investigation.

• Brand Name: SUPPORT ARM 178
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 10413449
• MDR Text Key: 203725316
• Report Number: 8010042-2020-00534
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6481720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/06/2022
• 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