BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 22035556 · Received May 16, 2025

    Report

    Report Number
    2518422-2025-044990
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER RECEIVED ON 05JUN2025, IT WAS STATED THAT THERE WERE NO PLANS TO CONTINUE TROUBLESHOOTING/REPAIR SERVICE AS OF THE TIME OF THE RESPONSE, AND THE DEVICE WAS PLANNED TO REMAIN OUT OF SERVICE FOR THE TIME BEING. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER ON 03JUN2025, IT WAS CONFIRMED THAT THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) HAD BEEN REPLACED. THE PART REPLACEMENT HAD NOT RESOLVED THE CUSTOMERS BACKUP BATTERY FAILED ALARM. THE CUSTOMER CONFIRMED THAT THE DEVICE REMAINED OUT OF USE AS OF THE TIME OF THE GFE RESPONSE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT, DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THERE WAS A BATTERY FAILURE ALARM PRODUCED. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER 06MAY2025, IT WAS CLARIFIED THAT A REPLACEMENT POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) HAD BEEN ORDERED FOR THE DEVICE PRODUCING A BACKUP BATTERY FAILED ALARM DURING PM. IN A SECOND GFE RESPONSE RECEIVED ON 12MAY2025, IT WAS CONFIRMED THAT THE ORDERED PM PCBA HAD BEEN RECEIVED AND INSTALLED IN THE DEVICE. THE REPLACEMENT PM PCBA DID NOT RESOLVE THE BACKUP BATTERY ISSUE, AND THE DEVICE HAS NOT BEEN RETURNED TO SERVICE AS OF THE TIME OF THE GFE RESPONSE ON 12MAY2025. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216110 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown