BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP SYNCHRONY ST

    MDR report key: 1241484 · Received November 21, 2008

    Report

    Report Number
    2518422-2008-00029
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 22, 2008
    Manufacturer
    RESPIRONICS INC
    Product Code
    MNS
    PMA / PMN Number
    K992530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR CONCLUDES THAT THE OFF-LABEL USES IDENTIFIED, NOT THE DESIGN OR OPERATION OF THE DEVICE, CAUSED AND OR CONTRIBUTED TO THE REPORTED EVENT. THE HOSP AND HEALTH CARE PROVIDERS WERE CONTACTED BY THE MFR TO VERIFY THEY WERE AWARE OF THE INTENDED USES OF THE DEVICE. DURING THIS CONTACT, IT WAS CONFIRMED THE CUSTOMER HAD THE BIPAP SYNCHRONY ST PROVIDER MANUAL. BASED ON THESE FINDINGS AND THE COMPLETION OF THE F/U WITH THE HEALTH CARE PROVIDER REGARDING THE INTENDED USE OF THE PROD, THE MFR CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT A PT USING A BIPAP SYNCHRONY ST WITH SUPPLEMENTAL OXYGEN WENT INTO RESPIRATORY ARREST AND SUBSEQUENTLY EXPIRED DURING USE OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. INVESTIGATION BY THE MFR IDENTIFIED THE DEVICE WAS BEING USED BOTH INVASIVELY AND TO PROVIDE THE TOTAL VENTILATORY REQUIREMENT FOR THE PT. BOTH OF THESE USES ARE CONTRARY TO PROD LABELING WHICH STATES (REFERENCE BIPAP SYNCHRONY ST PROVIDER MANUAL, PART # 1010709 REVISION 01) THE INTENDED USE OF THE DEVICE "IS TO PROVIDE NON-INVASIVE VENTILATION IN ADULT PTS", AND DO SO FOR A PT POPULATION WHO "CAN CONTINUE WITHOUT VENTILATION FOR SOME PERIOD OF TIME, SUCH AS OVERNIGHT." THE INVESTIGATION FURTHER DETERMINED THE PT DISCONNECT ALARM HAD BEEN DEACTIVATED AT THE TIME THE EVENT OCCURRED. THE DEACTIVATION OF PT ALARMS FOR MEDICAL REASONS IS CONTRARY TO PROD LABELING, AS STATED IN THE BIPAP SYNCHRONY ST PROVIDER MANUAL, PART # 1010709 REVISION 01, WHICH CALLS FOR USERS "TO VERIFY THE OPERATION OF THE PT DISCONNECT ALARM WITH ANY CHANGES IN THE PT CIRCUIT AND TO VERIFY THE ALARM IS ACTIVATED IF REQUIRED FOR MEDICAL REASONS". A REVIEW OF THE MFR'S COMPLAINT AND ADVERSE EVENT DATABASE FROM 2004 TO 2008 REVEALED NO SIMILAR EVENTS OR ADVERSE OUTCOMES RELATED TO THE DEACTIVATION OF THE PT DISCONNECT ALARM WHICH WOULD HAVE ALERTED THE CAREGIVER OF THE EVENT IF IT WAS NOT "DEACTIVATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP SYNCHRONY ST VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING MNS RESPIRONICS INC 1004304

    Patients

    Seq Age Sex Outcome Treatment
    1 Death