BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11241064 · Received January 27, 2021

    Report

    Report Number
    2031642-2021-00346
    Event Type
    Injury
    Date Received
    January 27, 2021
    Report Date
    February 15, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4:18FEB2021. B4:19FEB2021. H11:G5:K102985. H10: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A COVID-19 PATIENT WAS BEING VENTILATED WHEN THE DEVICE SHUTDOWN WITHOUT ANNUNCIATING AN ALARM. THE PATIENT WAS MOVED TO A DIFFERENT UNIT AS A RESULT. THE PATIENT DECOMPENSATED DURING THE DEVICE EXCHANGE BUT EXPERIENCED NO HARM. BASED ON THIS INFORMATION, THE TYPE OF REPORTED EVENT IS BEING UPDATED TO SERIOUS INJURY. THE HOSPITAL'S BIO-MED TOOK THE UNIT OUT OF SERVICE FOR EVALUATION AND REPORTED THAT IT COULD NOT BE TURNED BACK ON. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE FOR ADDITIONAL EVALUATION. THE FSE REPLACED THE REPLACED POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO RESOLVE THE REPORTED ISSUE. THE UNIT PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS PUT BACK INTO SERVICE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE POWER MANAGEMENT PRINTED CIRCUIT BOARD ASSEMBLY (PM-PCBA) WAS RETURNED TO PHILIPS FOR FAILURE INVESTIGATION ANALYSIS. UPON INSPECTION AND EVALUATION OF THE PM-PCBA, IT WAS DETERMINED THAT THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED WITH NO FAULT FOUND.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2021. DATE OF REPORT: 27JAN2021.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT THE DEVICE SHUT DOWN COMPLETELY AND WON'T POWER BACK ON. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136892 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown