BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11979818 · Received June 10, 2021

    Report

    Report Number
    2031642-2021-04039
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4: (B)(6) 2021. THE MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THE PSE REPLACED THE CENTRAL PROCESSING UNIT BOARD TO RESOLVE THE REPORTED PROBLEM. THE UNIT WAS CHECKED OVERALL, CLEANED, AND FUNCTIONALLY TESTED. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS.

    Additional Manufacturer Narrative · 0

    THE CPU PCBA WAS RETURNED FOR FAILURE INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT LS1'S BUILT WITHOUT A DATE CODE COULD BE SUBJECT TO COLD JOINTS WITHIN LS1 THAT CAN RESULT IN LS1 FAILING TO SOUND.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 10JUN2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT WHEN TURNING ON THE POWER FOR THE FIRST TIME, "BACKUP ALARM FAILED" ALARM OCCURRED. THE UNIT KEPT OPERATING AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE ISSUE WAS FOUND WHEN A PRE-USE CHECK WAS BEING PERFORMED AT THE HOSPITAL. THERE WAS NO DELAY IN THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874927 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENTILATOR,JAPAN OPT: CFLEX,AVAPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown