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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM
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MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM Back to Search Results
Model Number SUPPORT ARM 177
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the support arm broke.There was no patient harm.Manufacturer's ref #: (b)(4).
 
Manufacturer Narrative
No repair was requested and no parts were returned.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.Previous investigations of similar faults led to a redesign and change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.The support arm associated with this complaint had been manufactured before this change was implemented in production.
 
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Brand Name
SUPPORT ARM 177
Type of Device
SUPPORT, ARM
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer Contact
sara soderholm roman
roentgenvagen 2
solna 
MDR Report Key12802174
MDR Text Key280687095
Report Number8010042-2021-02695
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPPORT ARM 177
Device Catalogue Number6481720
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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