BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11898890 · Received May 27, 2021

    Report

    Report Number
    2031642-2021-03878
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    September 15, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE EVALUATION OF THE DEVICE, THE FIELD SERVICE ENGINEER REPLACED THE POWER MANAGEMENT PCBA TO RESOLVE THE PROBLEM. THE UNIT WAS THEN FUNCTIONALLY TESTED AND SUCCESSFULLY PASSED SPECIFIED TESTS. NO OTHER ABNORMALITY WAS OBSERVED. THE DEVICE CONTEXT OF USE IS UNKNOWN; HOWEVER, IT WAS NOTED THAT THE PROBLEM WAS FOUND PRIOR TO PATIENT USE, AND THERE WAS NO PATIENT HARM OR INJURY. ALTHOUGH REQUESTED TO BE RETURNED, THE REMOVED COMPONENT WAS NOT RECEIVED FOR EVALUATION AT THIS TIME; THEREFORE, THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED. AN EVALUATION WILL BE PERFORMED IF THE REMOVED COMPONENT IS RECEIVED, AND AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11 PATIENT INVOLVEMENT: THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT: IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Additional Manufacturer Narrative · 0

    THE POWER MANAGEMENT BOARD WAS RETURNED TO PHILIPS FOR EVALUATION. VISUAL INSPECTION OBSERVED NO ANOMALIES. FAILURE ANALYSIS WAS PERFORMED; THE ROOT CAUSE WAS DETERMINED TO BE A FAILURE OF SOLDER JOINTS AT R31.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 27MAY2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE BIOMED REPORTED THAT THE V60 BLOWER WILL NOT RUN AND HAS A 35 VOLT SUPPLY FAILED ERROR IN THE DIAGNOSTIC LOG. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT. THE PRODUCT SUPPORT ADVISED THE CUSTOMER THAT THE UNIT IS AFFECTED BY POWER MANAGEMENT BOARD FIELD CHANGE ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791780 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown