BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25190960 · Received May 15, 2026

    Report

    Report Number
    1417592-2026-01312
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    DXQ
    UDI-DI
    10080196738953
    PMA / PMN Number
    K211084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H8 RELATING TO INVESTIGATION FINDINGS/CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BLOOD PRESSURE CUFF WILL NOT INFLATE. THE ITEM REMAINS COMPRESSED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLOOD PRESSURE CUFF WILL NOT INFLATE. THE ITEM REMAINS COMPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429926 MEDLINE ANEROID,HAND HELD,LRG ADULT,NEOPRENE DXQ MEDLINE INDUSTRIES, LP 65125110001 10080196738953

    Patients

    Seq Age Sex Outcome Treatment
    1