BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM

    MDR report key: 5091341 · Received September 21, 2015

    Report

    Report Number
    2031642-2015-01853
    Event Type
    Death
    Date Received
    September 21, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 13, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT/USER INVOLVEMENT: THE PATIENT EXPIRED. PATIENT A MALE. NO FURTHER INFORMATION PROVIDED. THE DISTRIBUTORS SERVICE TECHNICIAN EVALUATED THE DEVICE. THE DEVICE PASSED TESTING. PER THE SERVICE TECHNICIAN REVIEW OF THE DIAGNOSTIC HISTORY LOG SHOWS THE DEVICE RESTART MULTIPLE TIMES WHILE IN USE. THERE WERE NO PARTS REPLACED. THE DEVICE IS CURRENTLY QUARANTINED. (B)(6).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS FOUND EXPIRED AND THE DEVICE WAS OFF. THE CUSTOMER REPORTED NO ALARM WAS HEARD. THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE DISTRIBUTOR THAT A PATIENT WAS FOUND DEAD DURING THE NIGHT OF (B)(6), AND INITIAL SURVEY FOUND THAT THE VENTILATOR WAS SHUT DOWN. NO ALARM WAS HEARD DURING THE NIGHT. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622192 BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death