BEUDAMED
    FDA Adverse Event Death Summary report: N

    LP6 PORTABLE VENTILATOR

    MDR report key: 121575 · Received September 18, 1997

    Report

    Report Number
    2024500-1997-00269
    Event Type
    Death
    Date Received
    September 18, 1997
    Report Date
    September 17, 1997
    Manufacturer
    NELLCOR PURITAN BENNET FORMERLY AEQUITRON MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE TRACH TUBE BECAME DISCONNECTED FROM A PT AND THE LOW PRESSURE ALARM DID NOT SOUND. PT WAS RECONNECTED AND THEN DISCONNECTED FROM VENTILATOR TO BE MANUALLY VENTILATED. VENTILATOR ALARMED AFTER TWO CYCLES. THE ALLEGED EVENT COULD NOT BE DUPLICATED. THE UNIT PASSED EXTENDED TESTING. IT IS NOT VERIFIED THAT THE ALARM DID NOT SOUND, AND NO MALFUNCTION MAY HAVE OCCURRED. THE DEVICE WAS RECERTIFIED AND RETURNED TO USE. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PRUITAN-BENNETT (FORMERLY AEQUITRON MEDICAL, INC) THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT. ORIGINAL DATE REPORT WAS REC'D BY AEQUITRON WAS 8/14/95. NELLCOR PURITAN BENNETT REC'D REPORT 8/18/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP6 PORTABLE VENTILATOR PORTABLE VENTILATOR CBK NELLCOR PURITAN BENNET FORMERLY AEQUITRON MEDICAL, INC. LP6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death