BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11142976 · Received January 8, 2021

    Report

    Report Number
    2031642-2021-00097
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    December 14, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:10MAR2021. B4:13MAR2021. THE CUSTOMER EVALUATED THE DEVICE WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE), AND IT WAS DETERMINED THAT THE POWER SWITCH OVERLAY NEEDED TO BE REPLACED TO RETURN THE DEVICE TO WORKING CONDITION. THE CUSTOMER¿S BIO-MED REPLACED THE POWER SWITCH OVERLAY TO RESOLVE THE ISSUE AND BRING THE DEVICE BACK TO FUNCTIONALITY. A SIMILAR INVESTIGATION WAS PERFORMED WAS DETERMINED TO BE DELAMINATION AND CRACKING OF THE ENCAPSULATE EPOXY ENCASING THE LIGHT EMITTING DIODE (LED) DICE, AND PHYSICAL SHEARING OF THE EPOXY OR TRACE CAUSING OPENED AND INTERMITTED TRACE CONTINUITY TO THE LED. 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) 2020. DATE OF REPORT: 08JAN2021.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A LED (LIGHT EMITTING DIODE) FAILURE. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33979 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1