BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8812236 · Received July 22, 2019

    Report

    Report Number
    2031642-2019-04911
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Report Date
    July 10, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC¿D BY MFR : 29JUL2019. THE MANUFACTURER¿S TECHNICAL SERVICES (TS) CONFIRMED THE REPORTED ISSUE. THE CUSTOMER WAS PROVIDED WITH THE PART NUMBER FOR THE POWER MANAGEMENT BOARD. THE CUSTOMER REPLACED THE DEFECTIVE POWER MANAGEMENT BOARD TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 22JUL2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERROR 35V SUPPLY FAILED (E/C 1115-AUXILIARY ALARM SUPPLY FAILED, 111B-35 V SUPPLY FAILED, 1104-BACKUP ALARM FAILED). ALSO,THE BLOWER DOES NOT RUN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604067 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1