BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11810867 · Received May 12, 2021

    Report

    Report Number
    2031642-2021-03684
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 12, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G5: 510(K)#: K102985. B4: (B)(6) 2021. H6: CODES WERE ADDED TO THIS REPORT. EVALUATION AND REPAIR INFORMATION WAS PREVIOUSLY SUBMITTED.

    Additional Manufacturer Narrative · 0

    A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE ISSUE. THE ISSUE WAS TRACED TO A SHATTERED TOUCHSCREEN, DAMAGED FRONT BEZEL, AND A CRACKED END CAP. DURING TESTING, THE FLOW SENSOR WAS FOUND TO BE LEAKING PRESSURE. THE TECHNICIAN REPLACED THE FRONT BEZEL, END CAP, AND FLOW SENSOR. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS RETURNED TO THE CUSTOMER. THIS REPORTER STATED THAT A PATIENT OF UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF MYCOBACTERIUM TUBERCULOSIS. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED BI-LEVEL POSITIVE AIRWAY PRESSURE (BI-PAP) THERAPY VIA THE RESPIRONICS V60 VENTILATOR; PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE WITH A FACE MASK; BRAND, MODEL AND SIZE NOT REPORTED, WHEN THEY WERE BEING DISCHARGED AND TRANSPORTED FROM THE MEDICAL SURGICAL FLOOR AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU) TO UNDERGO A SCHEDULED INTUBATION PROCEDURE WITH ORDERS FOR MECHANICAL VENTILATION, DUE TO THE PATIENT¿S DECOMPENSATING CONDITION. WHILE BEING TRANSPORTED, THE V60¿S SCREEN WENT BLANK AND DISPLAYED A RED BAR ALARM ACROSS IT¿S TOP, BUT NO AUDIBLE ALARM WAS GENERATED, THE DEVICE THEN DID NOT OPERATE FOR APPROXIMATELY 15 SECONDS, HOSPITAL STAFF REMOVED THE PATIENT¿S FACE MASK, THE DEVICE OPERATION RESUMED, THE FACE MASK WAS RE-APPLIED, THERAPY CONTINUED, AND THE PATIENT ARRIVED AND WAS ADMITTED TO THE ICU. NO ADVERSE EVENT WAS REPORTED OR ASSOCIATED WITH THE USE OF THIS DEVICE. NO RELEVANT LABORATORY DATA WAS REPORTED. THIS WAS A MALFUNCTION OF THE FRONT BEZEL AND END CAP.

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINT CANNOT BE VERIFIED. RETURNED GDS PASSES BOTH SYSTEM AND HIGH PRESSURE LEAK TESTS. NO FAULT FOUND. RETURNED BEZEL OPERATES NORMALLY. NO FAULT FOUND.

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED FROM 29JUN2021 INDICATED NO ADVERSE EVENT WAS REPORTED OR ASSOCIATED WITH THE USE OF THIS DEVICE. TYPE OF COMPLAINT UPDATED FROM SERIOUS INJURY TO PRODUCT PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE V60 REBOOTED AND NOW THE ALARM SILENCE WILL NOT FUNCTION. THE CUSTOMER STATED THE VENTILATOR SHUT OFF AND RESTARTED DURING TRANSPORT. THE ALARM INDICATED BI-PAP RESTART AND MACHINE FUNCTIONING, BUT ALARM SILENCE AND RESET NOT WORKING (GRAYED OUT). THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THE PATIENT INTUBATED AND PLACED ON ANOTHER VENTILATOR WITH NO ADVERSE OUTCOME REPORTED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE CUSTOMER REQUESTED THAT THE DEVICE BE RETURNED TO THE PHILIPS BENCH REPAIR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708201 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown