BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC PARAPAC WITH ALARMS

    MDR report key: 1482481 · Received September 23, 2009

    Report

    Report Number
    2182466-2009-00016
    Event Type
    Death
    Date Received
    September 23, 2009
    Date of Event
    July 20, 2009
    Report Date
    August 26, 2009
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL PM, INC. IMPORTS THE VENTILATOR FROM THE DISTRIBUTOR. SMITHS MEDICAL PM, INC. KITS A PATIENT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC. IS REPORTING AS THE MANUFACTURER. THE VENTILATOR WAS RETURNED TO SMPM TECHNICAL SERVICE DEPARTMENT FOR EVALUATION. SERVICE NOTED WHEN THE VENTILATOR IS TURNED ON, THE LEDS DO NOT CYCLE IN SEQUENCE, BUT ONLY THE LOW BATTERY INDICATOR LIGHT FLICKERS. ALSO, THERE WAS NO AUDIBLE ALARM. THE VENTILATOR WAS RETURNED TO DISTRIBUTOR FOR EVALUATION. THE DISTRIBUTOR FOUND THAT ELECTRONIC MONITORING ALARM BOARD HAD FAILED. ALL PNEUMATIC FUNCTIONS WERE FULLY OPERABLE WITHIN SPECIFICATION. FAILURE OF A CRYSTAL OSCILLATOR ON THE BOARD CAUSED THE WATCHDOG IC TO CONTINUALLY RESET, NOT ALLOWING THE MAIN IC TO START UP. ALL PNEUMATIC VISUAL AND AUDIBLE ALARMS WERE STILL FULLY FUNCTIONAL. THIS IS THE FIRST RECORDED FAILURE OF THIS TYPE. THIS TYPE OF ALARM BOARD HAS BEEN INSTALLED ON ALL ALARM VERSION VENTILATORS SINCE APRIL 2000. A NEW ALARM BOARD WAS TESTED AND INSTALLED IN THE VENTILATOR. THE VENTILATOR WAS THEN FULLY TESTED AND ALL FUNCTIONS WERE FOUND TO BE CORRECT. THE IFU WARNS THE USER TO KEEP CONSTANT CHECK ON THE ADEQUACY OF THE GAS SUPPLY.

    Description of Event or Problem · 1

    PRE-USE CHECKS WERE PERFORMED PRIOR TO THE VENTILATOR BEING ATTACHED TO THE PATIENT. THE PATIENT WAS MOVED FROM CRITICAL CARE TO CATHETER LAB FOR EMERGENCY INTERVENTION. THE GAS IN THE CYLINDER RAN OUT. NO ALARM SOUNDED OR DISPLAYED. WHEN THE PATIENT ARRESTED, THE VENTILATOR WAS IDENTIFIED AS NOT FUNCTIONING. THE INDICATOR LIGHT WAS NOT ILLUMINATED AND THE RESPIRATORY THERAPIST AND NURSING STAFF DID NOT HEAR AN ALARM SOUND. CPR WAS PERFORMED AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITH ALARMS EMERGENCY VENTILATOR BTL 120003V

    Patients

    Seq Age Sex Outcome Treatment
    1 Death