MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; BED, FLOTATION THERAPY, POWERED

Catalog Number 6481720

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the support arm of the ventilator broke.The patient involvement is unknown.(b)(4).

Event Description

Manufacturer ref.#: 1910mcc0877.

Manufacturer Narrative

The returned support arm was broken at the joint nearest to the bracket.An investigation of the edge of the break did not show any inaccuracies.The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.The support arm has been successfully tested for mechanical strength and is designed according to standard.It is unknown under which circumstances the support arm broke.

• Brand Name: SUPPORT ARM 177
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8425309
• MDR Text Key: 139168786
• Report Number: 8010042-2019-00176
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

2 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
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0