BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11206118 · Received January 20, 2021

    Report

    Report Number
    2031642-2021-00262
    Event Type
    Injury
    Date Received
    January 20, 2021
    Report Date
    February 17, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTION ON PATIENT CODING. H10: THE OXYGEN VALVE SOLENOID ASSEMBLY WAS RETURNED FOR FAILURE ANALYSIS AND TESTED, AND NO FAILURES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    G4:19FEB2021. B4:22FEB2021. H11:G5:K102985. H10: BASED UPON FURTHER INFORMATION RECEIVED BY PHILIPS, PATIENT INJURY WAS NOTED DURING THE EVENT RESULTING IN A SEVERE DECREASE TO SATURATION OF PERIPHERAL OXYGENATION (SPO2) TO 85%. DEVICE INVESTIGATION HAS BEEN CONDUCTED WITH NO FAILURE OR MALFUNCTION TO DECLARED MANUFACTURER SPECIFICATIONS FOUND OR NOTED. DUE TO THE PATIENT INJURY INCURRED, ADDITIONAL REPORTING WILL BE CONDUCTED TO RELEVANT COMPETENT AUTHORITIES WITH THE FINDINGS OF SERIOUS INJURY WITH NO CAUSE OR CONTRIBUTION FROM THE V60 VENTILATOR. G4:22FEB2021. B4:22FEB2021. H10: THIS REPORTER STATED THAT A MALE PATIENT OF UNKNOWN AGE, 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. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) THERAPY VIA THE RESPIRONICS V60 VENTILATOR. S/T MODE SETTINGS: IPAP:14 HPA, EPAP:4 HPA, RATE: 10 BPM, O2:100%, I-TIME:1.00 SECS, RISE:1, ALARM SETTINGS: HI RATE:40 BPM, LO RATE:4 BPM, HI VT:1000ML, LO VT:OFF HIP:50 HPA, LIP:4 HPA, LO VE:OFF, LIP T:20SECS. WHILE ADMITTED ON (B)(6) 2020, THE PATIENT WAS RECEIVING BIPAP THERAPY VIA THE V60 DEVICE, THE FIO2 WAS SET TO 70% WITH THE OXYGEN SOURCE CONNECTED TO THE WALL SUPPLY, THE DEVICE GENERATED AN OXYGEN NOT AVAILABLE ALARM, AND THE PATIENT EXPERIENCED AN EVENT OF DECREASED PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) TO 85%. HOSPITAL STAFF THEN PLACED THE PATIENT ON ANOTHER V60 DEVICE, AND THE EVENT OF OXYGEN DESATURATION RESOLVED; VALUES NOT REPORTED. NO DIAGNOSTIC REPORT WAS PROVIDED FOR REVIEW. 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: 20JAN2021.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "OXYGEN NOT AVAILABLE" ALARM OCCURS AFTER FIO2 WAS SET TO 70%. THE UNIT WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR THE USER. THE MANUFACTURER'S INTERNATIONAL SERVICE TECHNICIAN COULD NOT CONFIRM THE REPORTED ISSUE. PERFORMED THE OXYGEN FLOW ACCURACY/OXYGEN CONCENTRATION ACCURACY TEST, BUT NO ISSUE WAS CONFIRMED. THE MANUFACTURER'S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE SOLENOID VALVE PREVENTIVELY. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100624 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838033832

    Patients

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