BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 3231973 · Received July 15, 2013

    Report

    Report Number
    2518422-2013-01400
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE SERVICE EVAL FOUND THAT THE BATTERY WAS UNABLE TO REACH FULL CHARGE CAPACITY DUE TO NORMAL WEAR ASSOCIATED WITH RECHARGEABLE BATTERIES. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. A REVIEW OF THE DEVICE'S SERVICE RECORD INDICATES THE DEVICE HAS NOT RETURNED FOR PREVENTIVE MAINTENANCE SINCE 2004. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MANUFACTURER'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING THE INTERNAL BATTERY WAS NOT LASTING AS LONG AS EXPECTED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327783 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1