BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM PSV

    MDR report key: 166111 · Received May 6, 1998

    Report

    Report Number
    MW4002206
    Event Type
    Death
    Date Received
    May 6, 1998
    Date of Event
    April 25, 1998
    Report Date
    April 30, 1998
    Manufacturer
    HEALTHDYNE, INC.
    Product Code
    MNS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT'S WIFE CALLED AFTER HRS DESCRIBING "MACHINE NOT WORKING". UPON RETURN PHONE CALL (PT HAD AMIOTROPYC LATERAL SCLEROSIS). THE ALARM WAS TIED TO "PT SYS ALARM". PT'S WIFE STATED SHE COULD "FEEL IT WORKING" BUT THAT HER HUSBAND COULDN'T BREATHE, WAS CHOKING. RPTR ADVISED "911" TO BE CALLED. THE QUANTUM UNIT WAS REPOSITIONED PER RESPIRATORY THERAPIST INSTRUCTION & REAPPLIED TO PT. IT FUNCTIONED WITH PROPER PHYSICIAN SETTINGS AND WITH NO ALARMS UNTIL THE EVENING OF 4/27/98 WHEN THE NEXT PT EVENT OCCURRED. A RESPIRATORY THERAPIST RESPONDED TO THE HOME & VERIFIED THAT THE SETTINGS WERE AS PRESCRIBED. THE QUANTUM PT DID NOT APPEAR TO HAVE ANY NEGATIVE INSPIRATORY VOLUME OR TO BE MOVING ANY TITAL VOLUME. THE QUANTUM WAS SWITCHED OUT TO A NEW QUANTUM BUT THE SAME "PT AT RESPONSE WAS OBSERVED". AT THAT POINT THE RESPIRATORY THERAPIST INITIATED OXYGEN AT 15% PER NON-REBREATHER MASK. PHONED TO PHYSICIAN. THE PT HAD AMIOTROPYC LATERAL SCLEROSIS AND WAS A DO NOT RESUSCITATE. THE FAMILY HAD BEEN ADVISED CONCERNING INITIATION OF A VOLUME VENTILATOR INSTEAD OF THE QUANTUM BUT RESISTED THIS ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM PSV NONINVASIVE POSITIVE PRESSURE DEVICE MNS HEALTHDYNE, INC. 7700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death