BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10738360 · Received October 26, 2020

    Report

    Report Number
    2031642-2020-03866
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    October 5, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020, DATE OF REPORT: 26OCT2020.

    Description of Event or Problem · 1

    THE BIOMED REPORTED LIGHT EMITTING DIODE (LED) FAILED WHEN POWERING ON THE UNIT. THE BIOMED CONFIRMED AN ERROR CODE CONSISTENT WITH ALARM LED FAILURE IN THE SIGNIFICANT EVENT LOGS. THE BIOMED WAS NOT SURE IF LED LIGHTS ARE WORKING. THE REMOTE MANUFACTURE SERVICE TECHNICIAN EMAILED THE BIOMED THE PART NUMBER OF THE POWER SWITCH OVERLAY. THE BIOMED IS GOING TO SEE IF THAT RESOLVES THE ISSUE. THE DEVICE DID NOT HAVE PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, THEREFORE, THERE WAS NO PATIENT OR USER HARM REPORTED. THE BIOMED CONFIRMED WITH THE REMOTE MANUFACTURE SERVICE TECHNICIAN THAT THE ISSUE HAS BEEN RESOLVED AFTER REPLACING THE POWER SWITCH OVERLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203159 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1