BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1030169 · Received April 14, 2008

    Report

    Report Number
    2031702-2008-00069
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE VENTILATOR WAS NOT RETURNED IN ITS ORIGINAL CONDITION. THE POWER BOARD HAD BEEN REPLACED IN THE VENTILATOR FOR THE CAPACITOR RECALL PRIOR TO SENDING THE UNIT BACK FOR EVAL. UNABLE TO LOCATE THE ORIGINAL POWER BOARD FOR TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER SENT THE VENTILATOR TO A SERVICE CENTER FOR RECALL SERVICE. A NOTE WITH THE VENTILATOR REPORTED THE VENTILATOR WAS "NOT BLOWING AIR". THIS NOTE WAS FOUND AFTER THE RECALL REWORK WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1