BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15836909 · Received November 21, 2022

    Report

    Report Number
    2031642-2022-02936
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 27, 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

    THE BEZEL THAT WAS BROUGHT TO THE PRODUCT INVESTIGATION LAB (PIL) WITH THE ACCUSATION OF: THE NAVIGATION RING WAS NOT RESPONDING. THE NAVIGATION RING FAILURE WAS VERIFIED DURING ITS ATTEMPTED USE ON THE PIL HOSPITAL VENT STANDARD TEST BED. THE PIL TECH PERFORMED A TEMPORARY INSTALL OF THE PCA (P/N 1050393) PORTION OF THE NAVIGATION RING BUT VERIFIED THAT THIS DID NOT FIX THE ISSUE. THE PIL TECH VERIFIED THAT THE NAVIGATION RING ISSUE WAS DUE TO THE PORTION OF THE NAVIGATION RING THAT IS FITTED INTO THE BEZEL ITSELF. THE ACCEPT BUTTON DID OPERATE AS EXPECTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE NAVIGATION RING WAS NOT RESPONDING. IT WAS 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 THAT THE NAVIGATION RING WAS NOT RESPONDING AT ALL DURING INSPECTION. THE PSE REPLACED THE FRONT BEZEL TO RESOLVE THE ISSUE, AND NO OTHER ANOMALY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346750 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 NA Unknown