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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 178; SUPPORT, ARM
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MAQUET CRITICAL CARE AB SUPPORT ARM 178; SUPPORT, ARM Back to Search Results
Model Number SUPPORT ARM 178
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2023
Event Type  malfunction  
Manufacturer Narrative
It was claimed that support arm 178 mounted on servo-u ventilator has been broken.There was no patient harm.Based on technician statement, the there is no information how breakage occurred.According to the provided photo, support arm broke on the locking joint.Whole arm has been replaced to resolve the issue.The device was delivered to the user in working condition.Broken/damaged support arm may lead to stop of ventilation (extubation) or injury.The part has been not available for the further analyze of the issue.Therefore, the root cause of the issue could not be determined.
 
Event Description
It was reported that the support arm has been broken.There was no patient harm.Manufacturer's ref #: (b)(4).
 
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Brand Name
SUPPORT ARM 178
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 Key16681671
MDR Text Key312692626
Report Number8010042-2023-00695
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeHK
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 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPPORT ARM 178
Device Catalogue Number6693715
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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