BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8898736 · Received August 15, 2019

    Report

    Report Number
    2031642-2019-06231
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Report Date
    July 29, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 15AUG2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING AND CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED THE CENTRAL PROCESSING UNIT BOARD AND THE ISSUE WAS RESOLVED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DECLARED A 35 VOLT FAILURE (E/C 111B), AUXILIARY ALARM SUPPLY FAILURE (E/C 1115) AND A BACKUP ALARM FAILURE (E/C 1104). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689789 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1