BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15115401 · Received July 27, 2022

    Report

    Report Number
    2031642-2022-01973
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    July 8, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE: 0120-556-494.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TECHNICAL SUPPORT (TS) AND REPORTED THAT THE DEVICE HAS A 24V SUPPLY FAILED ALARM (DIAGNOSTIC CODE: 111A). THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THE PSE REPLACED THE POWER SUPPLY TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS. BASED ON INFORMATION PROVIDED AND/OR SERVICE PERFORMED IT HAS BEEN CONFIRMED UNIT DID NOT MEET PRODUCT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704091 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown