BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10988429 · Received December 10, 2020

    Report

    Report Number
    2031642-2020-04489
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    November 13, 2020
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:11FEB2021. B4:17FEB2021. THE CUSTOMER EVALUATED THE DEVICE WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE RSE ADVISED THE CUSTOMER THAT THE ALARM LED(LIGHT EMITTING DIODE) FAILURE'S RECOMMENDED REPAIR IS TO REPLACE THE POWER SWITCH OVERLAY. 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, AND THE PRIMARY MODE OF FAILURE FOR THIS OVERLAY HAS BEEN DETERMINED TO BE DELAMINATION AND CRACKING OF THE ENCAPSULATE EPOXY ENCASING THE 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: 10DEC2020.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT WHEN THE DEVICE WAS ACTIVATED THERE WAS A ALARM 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
    1446710 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1