MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM

Catalog Number 6481720

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Further info regarding the event has been sought.A supplemental medwatch report will be submitted when the investigation is completed.

Event Description

It was reported that the support arm for the ventilator broke.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).According to information received, the support arm broke at the joint above the first bend.The support arm is by design a casting product.No parts or pictures were received back for investigation.Neither was information of how or under which circumstances the support arm broke received.Previous investigations of the support arm led to a change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.This change was implemented in production during september 2009.It is unknown if the reported support arm was manufactured before, or after, the implementation of this change.Therefore, the cause for this event cannot be determined.

Event Description

(b)(4).This follow-up medwatch was created from a previously received initial medwatch with manufacturer report # : 8010042-2015-00356.The original date of the initial medwatch report was 07/24/2015.(b)(4).

• Brand Name: SUPPORT ARM 177
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: magnus lindqvist ; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW ; 7307705
• MDR Report Key: 5015125
• MDR Text Key: 24050794
• Report Number: 8010042-2015-00356
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• 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
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1