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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 179; SUPPORT, ARM
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MAQUET CRITICAL CARE AB SUPPORT ARM 179; SUPPORT, ARM Back to Search Results
Model Number SUPPORT ARM 179
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
It was reported that the support arm holding the patient tubes broke.There was no patient involvement.Manufacturer's ref #: (b)(4).
 
Manufacturer Narrative
Based on the provided problem description, photos, and the information from the customer, it has been clarified that the support arm has been broken.The user replaced the defective part and put back the unit for usage.According to support arm installation instructions, in the specification of the maximum capacity, it is stated how many kilograms can be loaded depending on the angle of use of the accessories (max.Approx.3 kg).The root cause to the reported issue has not been determined.
 
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Brand Name
SUPPORT ARM 179
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 Key18667379
MDR Text Key334850703
Report Number8010042-2024-00260
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K192604
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 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPPORT ARM 179
Device Catalogue Number6882001
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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