BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AF531 FULL FACE MASK

    MDR report key: 3202208 · Received June 28, 2013

    Report

    Report Number
    2518422-2013-01263
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 11, 2013
    Report Date
    June 3, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNS
    PMA / PMN Number
    K101130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS UNABLE TO CONFIRM THE ALLEGATION BECAUSE NO PRODUCT IS AVAILABLE FOR INVESTIGATION. BASED ON THE INFO AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT A PT BECAME DISCONNECTED FROM AN AF531 FULL FACE MASK WHILE THE PT WAS USING A BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE AND 40% SUPPLEMENTAL OXYGEN, CAUSING THE PT TO DESATURATE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE MASK WAS DISCARDED BY THE REPORTING FACILITY AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295930 AF531 FULL FACE MASK VENTILATOR, CONTINUOUS, NON-LIFE SUPPORT MNS RESPIRONICS INC. 1061727

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR