BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT STAR

    MDR report key: 81567 · Received March 31, 1997

    Report

    Report Number
    2024170-1997-00010
    Event Type
    Malfunction
    Date Received
    March 31, 1997
    Report Date
    March 3, 1997
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RETURNED ALARM DRIVER PCA FROM DEVICE WITHOUT ANY FAILURE DETAILS. WHEN THEY WERE CONTACTED TO OBTAIN THIS INFO, THEY STATED THAT A MALFUNCTION OF THE PCA OR CONNECTION TO THE PCA ALLEGEDLY CAUSED NO ALARMS TO SOUND ON THE UNIT. THIS WAS FOUND DURING MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT STAR ULTRA HIGH FREQUENCY VENTILATOR CBK NELLCOR PURITAN BENNETT 1010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA