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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 176; SUPPORT, ARM
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MAQUET CRITICAL CARE AB SUPPORT ARM 176; SUPPORT, ARM Back to Search Results
Model Number SUPPORT ARM 176
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 12/14/2020
Event Type  malfunction  
Event Description
It was reported that the support arm was damaged.The patient involvement was unknown.(b)(4).
 
Event Description
Manufacturer's ref#: (b)(4).
 
Manufacturer Narrative
The evaluation of the returned picture shows that the support arm broke at the bracket.The support arm bracket is a casting and it most probably developed a crack at an earlier occasion either by overloading or an impact exceeding the limits stated in the installation instructions.If the support arm would break during patient treatment, it could in worst-case lead to extubation and/or injury.Previous investigations led to a redesign and 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.The age of the support arm is unknown, but the connected ventilator is manufactured in the year 2006.The reported support arm is most likely manufactured during the same time period, before the implementation of the manufacturing change.
 
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Brand Name
SUPPORT ARM 176
Type of Device
SUPPORT, ARM
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11139158
MDR Text Key225760132
Report Number8010042-2021-00019
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPPORT ARM 176
Device Catalogue Number6405976
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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