MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 178; SUPPORT, ARM

Catalog Number 6693715

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the support arm for patient tubes fell of the side rail of the ventilator.There was no patient involvement.(b)(4).

Manufacturer Narrative

It was noted that the rail clamps double push button design with the 2 ball bearings tends to get stuck in the adjustment position and don¿t always release.This has most likely contributed to the disengaging of the support arm from the ventilator carrier.The root cause why the reported support arms lever actuator got stuck has not been established due to the lack of returned part.Work on an improved rail clamp is currently underway by by our research and development department.

Event Description

Importer ref.#:(b)(4).Manufacturer ref.#: 1909mcc0859.

• Brand Name: SUPPORT ARM 178
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8404259
• MDR Text Key: 138517884
• Report Number: 8010042-2019-00147
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6693715
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1