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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 Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Manufacturer Narrative
The support arm was not investigated by our field service engineer.The support arm was reportedly broken at the clamp attachment and was discarded.Provided picture confirms the reported damage.The root cause of the broken support arm has not been conclusively determined but most likely has it been exposed to a mechanical force greater than it is designed to sustain.
 
Event Description
It was reported that the support arm holding the patient circuit broke.Patient involvement is unknown.Manufacturer's ref #: (b)(4).
 
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Brand Name
SUPPORT ARM 176
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
caroline kabbabe
roentgenvagen 2
solna 
MDR Report Key16224060
MDR Text Key307905373
Report Number8010042-2023-00161
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2023
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 Received11/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/07/2005
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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