BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE MEDVAC MANUAL VACUUM PUMP

    MDR report key: 20980117 · Received December 18, 2024

    Report

    Report Number
    MW5163770
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    December 16, 2024
    Report Date
    December 16, 2024
    Manufacturer
    DOMICO MED-DEVICE
    Product Code
    FZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MEDVAC MANUAL VACUUM PUMP IS MRI CONDITIONAL AS STATED BY DOMICO MED-DEVICES, AND THAT THE ITEM CONTAINS NO MAGNETICALLY ATTRACTED MATERIALS, SO IT MAY SAFETY BE TAKEN INTO THE MAGNET ROOM. THIS IS INCORRECT. WHEN THE PUMP WAS WANDED WITH A FERROUS DETECTOR, THE DETECTOR ALARMED. THE PUMP WAS TAKEN INTO OUR 3T MAGNET AND THE PUMP HAD PULL AND WAS ATTRACTED TO THE MAGNET. THE ITEM IS LABELED AS "CONDITIONAL" AS DEFINED BY FDA CONSENSUS STANDARD ASTM F-2503-13, AND ACCORDING TO THE FDA -THIS CONSENSUS STANDARD CANNOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628112 THE MEDVAC MANUAL VACUUM PUMP SPLINT, EXTREMITY, INFLATABLE, EXTERNAL FZF DOMICO MED-DEVICE 27625 010611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention