BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    740 VENTILATOR SYSTEM

    MDR report key: 171708 · Received June 5, 1998

    Report

    Report Number
    2024500-1998-00161
    Event Type
    Malfunction
    Date Received
    June 5, 1998
    Report Date
    June 2, 1998
    Manufacturer
    PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COUNTRY CODE WAS CORRECTED IN 8020893-1998-0002. THE PSOL PCB WAS NEVER RETURNED BY THE RPTR AFTER SEVERAL ATTEMPTS TO GET THE PART BACK. SIMILAR COMPLAINTS WERE RECEIVED IN TWO OTHER INSTANCES. THE PARTS FROM THESE COMPLAINTS WERE RETURNED FOR EVAL AND ON EACH BOARD HAIRLINE CRACKS WERE FOUND ON CAPACITOR C122. CORRECTIVE ACTION (CO 123633) HAS BEEN IMPLEMENTED. THE NEW REVISION OF THE PSOL PCB HAS BEEN IMPLEMENTED IN MFG.

    Description of Event or Problem · 1

    THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THERE WAS NO ALARM SOUND ON A 740 VENTILATOR. LITTLE ADDITIONAL INFO HAS BEEN AVAILABLE. THE DISTRIBUTOR IS SENDING THE PART REPLACED BACK TO THE MFR FOR EVALUATION. IT IS NOT VERIFIED THAT THE UNIT HAD NO ALARM SOUND, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PURITAN-BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 740 VENTILATOR SYSTEM VOLUME VENTILATOR CBK PURITAN BENNETT 740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN