BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 9717088 · Received February 17, 2020

    Report

    Report Number
    2031642-2020-00522
    Event Type
    Death
    Date Received
    February 17, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 6, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 08JUN2020. B4: 17JUL2020. A REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND PERFORMED A CHECK ON THE UNIT BASED ON THE CHECK SHEET PROVIDED BY THE MANUFACTURER AND CONFIRMED THERE WAS NO ABNORMALITY WITH THE DEVICE. THE DEVICE EVENT LOGS/ERROR LOGS (DRPT) ARE NOT AVAILABLE FOR REVIEW. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH 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 THE ADMITTING DIAGNOSIS NOT REPORTED. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. DURING THE ADMISSION ON AN UNKNOWN DATE, THE PATIENT HAD SPONTANEOUS RESPIRATIONS AND WAS PRESCRIBED VENTILATION THERAPY VIA THE RESPIRONICS V60 VENTILATOR, WITH PATIENT CIRCUIT 1137263 VISION HEATED HUMIDIFIER DISPOSABLE CIRCUIT, PRODUCT NUMBER 1136818, AND FACE MASK 1079078 AF811 GEL FULL FACE, SIZE M, PRODUCT NUMBER 1063052. THE VENTILATOR SETTINGS WERE REPORTED AS DEFAULT SETTINGS, WITH THE ALARM VOLUME SET TO 5 WITH THE ALARM VOLUME ESCALATION FEATURE NOT IN USE. WHILE ADMITTED, ON 05FEB2020, THE PATIENT WAS RECEIVING THERAPY FROM THE V60 AND A CIRCUIT DISCONNECTION AT CIRCUIT AND MASK CONNECTION OCCURRED, THE PATIENT EXPERIENCED AN EVENT OF DECREASED PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2); RESULTS NOT REPORTED, WHICH WAS BEING MONITORED REMOTELY AT THE NURSES¿ STATION, THE DEVICE DID NOT GENERATE ANY AUDIBLE OR VISUAL ALARMS, AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO ANOTHER VENTILATOR, IT IS UNKNOWN IF THE PATIENT¿S THERAPY WAS CHANGED TO INVASIVE POSITIVE PRESSURE VENTILATION (IPPV), IT IS UNKNOWN IF ANY RESCUE EFFORTS WERE ADMINISTERED. NO RELEVANT LABORATORY DATA WAS REPORTED. THE REPAIR BENCH WAS NOT ABLE TO CONFIRM THE REPORTED DEVICE BEHAVIOR. THE CAUSE CANNOT BE DETERMINED BECAUSE THE PROBLEM COULD NOT BE RECREATED. 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 · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 17FEB2020.

    Description of Event or Problem · 1

    WHILE IN USE AND PROVIDING THERAPY TO THE PATIENT, REMOTE MONITORING OF SPO2 VIA NURSES STATION SHOWED MARKED DECREASE, PROMPTING THE NURSE TO PERFORM ASSESSMENT OF PATIENT. UPON ARRIVAL, THE NURSE DISCOVERED A CIRCUIT DISCONNECTION AT CIRCUIT AND MASK CONNECTION. THE NURSE STATES NO ALARMS WERE PRESENT OR HAD OCCURRED. PATIENT SENTINEL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180747 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER