BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8401527 · Received March 7, 2019

    Report

    Report Number
    2031642-2019-01350
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Report Date
    February 12, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 07MAR2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED REMOTE TROUBLESHOOTING WITH THE CUSTOMER. THE PNEUMATICS PAGE INDICATED THAT THE 35 VOLT DISPLAY READ ZERO. THE FSE RECOMMENDED THAT THE CUSTOMER REPLACE THE POWER MANAGEMENT BOARD. THE CUSTOMER REPLACED THE POWER MANAGEMENT BOARD AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DECLARED MULTIPLE ERRORS [BLOWER STALLED (1134), AUXILIARY ALARM SUPPLY FAILED (1115), 35 VOLT SUPPLY FAILED (111B) , BACKUP ALARM FAILED (1104), VENTILATOR RESTART DUE TO ANOMALIES (1101)]. THERE WAS NO PATIENT INVOLVEMENT. EVENT DATE NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194270 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1