BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16544354 · Received March 15, 2023

    Report

    Report Number
    2518422-2023-06869
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 14, 2023
    Report Date
    May 15, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838033832
    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

    H10: THE REPAIR FOR THIS UNIT CANNOT BE CONDUCTED AT THIS TIME DUE TO THE PART(S) BEING ON BACKORDER. THE MATERIAL HAS ALREADY BEEN REQUESTED AND AN ORDER FOR THE PART(S) WAS PLACED TO CONDUCT THE REPAIR OF THIS UNIT. THE MATERIAL ORDERED USER INTERFACE BOARD ALIGNS WITH THE RECOMMENDED REPAIR OF THE ALLEGED MALFUNCTION PER THE SERVICE MANUAL. WHEN THE PARTS BECOME AVAILABLE THE REPAIRS WILL BE CONDUCTED. IF NEW INFORMATION IS RECEIVED AND SUGGEST THAT THE DEVICE HAS ADDITIONAL MALFUNCTIONS, THE RECORD WILL BE REOPENED, AND AN INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. IT WAS REPORTED THAT DURING PRE-DELIVERY CHECK THE VENTILATOR STARTED UP ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE DEVICE AND CONFIRMED THAT THE UNIT STARTED UP ON ITS OWN. USER INTERFACE BOARD (2NDGEN, PN:1100786) NEEDS TO BE REPLACED. SINCE THE USER INTERFACE BOARD IS SUBJECT TO THE DELIVERY HOLD, THE SCHEDULED REPAIR COMPLETION DATE HAS NOT BEEN FIXED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164936 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1