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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM; SUPPORT, ARM
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MAQUET CRITICAL CARE AB SUPPORT ARM; SUPPORT, ARM Back to Search Results
Model Number SUPPORT ARM
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 12/10/2020
Event Type  malfunction  
Event Description
It was reported that the support arm for patient hoses were damaged.Patient involvement is unknown.Manufacturer's ref #: (b)(4).
 
Manufacturer Narrative
It was reported that the support arm for patient hoses was damaged.The evaluation of the received picture shows that the support arm has broken directly at the joint of the arm.The arm was not returned for investigation.The support arm is a casting and it probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.A change of the manufacturing process in order to obtain a higher mechanical strength of the support arm was implemented in production during september 2009.The reported ventilator was manufactured in october 2009, why it is likely that this arm was manufactured before the production change.
 
Event Description
Manufacturer's ref #: (b)(4).
 
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Brand Name
SUPPORT ARM
Type of Device
SUPPORT, ARM
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11044791
MDR Text Key222724259
Report Number8010042-2020-01275
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 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPPORT ARM
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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