BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON - INVASIVE VENTILATOR

    MDR report key: 6128663 · Received November 23, 2016

    Report

    Report Number
    MW5066337
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 20, 2016
    Report Date
    November 23, 2016
    Manufacturer
    PHILLIPS RESPIRONICS
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE ON NON-INVASIVE VENTILATOR, NURSE NOTICED PT WAS STRUGGLING TO BREATHE. RESPIRATORY THERAPIST CAME TO ROOM. TWO ALARMS WERE SEEN: "INLINE PRESSURE LOW" AND "PROXIMAL PRESSURE LOW." PT'S OXYGENATION LEVEL DROPPED INTO THE 40S. PT WAS PLACED ON A NON-REBREATHER MASK. CORRECTIONS WERE DOUBLE CHECKED BUT NOTHING APPEARED WRONG WITH EQUIPMENT. NEW EQUIPMENT OBTAINED. PT DID EXPERIENCE CHEST PAIN AND HIS TELEMETRY MONITORING SHOWED ST DEPRESSION. HE NEEDED ONE DOSE OF NITROGLYCERIN. HE RETURNED TO BASELINE FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776124 NON - INVASIVE VENTILATOR NON - INVASIVE VENTILATOR MNT PHILLIPS RESPIRONICS V 60

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR