BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PRESSUREEASY CUFF PRESSURE MONITOR

    MDR report key: 13862748 · Received March 23, 2022

    Report

    Report Number
    3012307300-2022-05071
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 21, 2022
    Report Date
    March 22, 2022
    Manufacturer
    ST PAUL
    Product Code
    BXR
    PMA / PMN Number
    K873498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR EVALUATION IN RELATION TO THE REPORTED EVENT. SENSORY INSPECTION OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT. REPORTED UNUSUAL ODOR WAS NOT NOTICED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE REPORTED EVENT WAS NOT CONFIRMED. A DHR REVIEW WAS NOT PERFORMED AS IT WAS NOT NECESSARY FOR THE INVESTIGATION OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE DEVICE HAD A BAD SMELL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990211 PORTEX PRESSUREEASY CUFF PRESSURE MONITOR METER, AIRWAY PRESSURE (INSPIRATORY FORCE) BXR ST PAUL 4180778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown