BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 478687 · Received August 13, 2003

    Report

    Report Number
    2031702-2003-00219
    Event Type
    Malfunction
    Date Received
    August 13, 2003
    Report Date
    August 13, 2003
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEMS, INC. RECEIVED THE FOLLOWING REPORT FROM A REP MEDICAL SUPPLIER: VENT SHUT DOWN WHILE ON PT ON MULTIPLE OCCASIONS, ON ALLEGED MULTIPLE POWER SOURCES (AC, CIG LIGHTER PLUG, ETC). ALARM INFO UNCONFIRMED - STATES ON 1 EVENT, VENT BEEPED THEN SHUT DOWN, OTHER TIME - NO ALARM. ADD'L EVENT DESCRIPTION: VENT SHUT IT'S SELF OFF. 1 TIME ON EXTERNAL BATTERY, 2ND TIME ON VAN POWER, BOTH TIMES DID NOT SWITCH TO INTERNAL POWER. ACCESSORIES USED: HUMIDIFIER, HME. RT STATED THE EXTERNAL BATTERY THAT WAS BEING USED AT THE TIME OF EVENT WAS 1-2 YEARS OLD AND THEY ARE CHARGING THE BATTERY DAILY (80% OF THE TIME THE BATTERY IS BEING FULLY DISCHARGED), PER PT NURSE. RT REQUESTED THE BATTERY BE REMOVED FROM THE HOME. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other