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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 Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Event Description
It was reported that there was an issue with the ventilator's support arm.No more information was available.There was no patient harm reported.Manufacturer's ref.#: (b)(4).
 
Manufacturer Narrative
It was reported that there was an issue with the ventilator's support arm.The ventilator was investigated on site by our field service engineer and issue resolved by replacing the broken support arm.However, no part returned for investigation.Therefore, no root cause can be established.
 
Event Description
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 Key18300177
MDR Text Key330158618
Report Number8010042-2023-02417
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2023
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
Is the Reporter a Health Professional? No
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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