BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASYS

    MDR report key: 1603337 · Received October 27, 2009

    Report

    Report Number
    2021710-2009-00044
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    March 10, 2009
    Report Date
    October 26, 2009
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CBK
    PMA / PMN Number
    K013642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K#: K022674, K062093, K073069. (B) (4). (B) (4): (B) (4). BASED ON THE REPORTED EVENT OF "BIOMEDICAL ENGINEERING RECEIVED THE VENTILATOR REPLACED THE BATTERY, CHARGED THE BATTERY AND THE VENTILATOR PASSED TESTING". WE CAN ONLY ASSUME THAT THE BATTERY WAS WORN OR IMPROPERLY MAINTAINED AS THE MATERIALS WERE NOT RETURNED FOR EVALUATION. THE AVEA OPERATORS MANUAL ON PAGE # 7-4 STATES THE AVEA HAS AN INTERNAL NICKEL METAL HYDRIDE BATTERY PACK THAT WILL PROVIDE POWER BACKUP FOR SHORT PERIODS IN THE EVENT THAT THE MAINS POWER SUPPLY IS LOST. UNDER NORMAL OPERATION CONDITIONS AND WHEN FULLY CHARGED, THE INTERNAL BATTERY IS CAPABLE OF POWERING THE VENTILATOR FOR 1 HOUR OR THE VENTILATOR AND COMPRESSOR FOR 30 MINS. THERE IS NO MENTION OF AN EXTERNAL BACKUP BATTERY IN USE AT THE TIME OF THE CUSTOMER REPORTED EVENT. THE AVEA OPERATORS MANUAL ON PAGE # 7-4 UNDER NOTE STATES. "SHOULD YOU WISH TO PERFORM INTRA-FACILITY TRANSPORT OF PTS YOU SHOULD EQUIP YOUR INSTRUMENTS WITH THE OPTIONAL EXTERNAL BATTERY. THE ADDITION OF THE EXTERNAL BATTERY WILL EXTEND THE TIME PERIOD TO 2 HOURS FOR VENTILATOR AND COMPRESSOR." IN CONCLUSION, WE HAVE IDENTIFIED THE FOLLOWING, BASED ON THE CUSTOMER REPORTED INFO, IT APPEARS THAT THIS EVENT IS ASSOCIATED WITH A LACK OF BATTERY MAINTENANCE, AND THE CUSTOMER UNITS DID NOT HAVE AN EXTERNAL BATTERY SYSTEM INSTALLED DURING TRANSPORT.

    Description of Event or Problem · 1

    (B) (4). "TITLE: XXXXX. EVENT DESC: DURING TRANSPORTATION OF A PT FROM ONE CRITICAL CARE UNIT TO ANOTHER, THE AVEA VENTILATOR'S BATTERY UNEXPECTEDLY DIED AFTER LESS THAN FIVE MINS. THE VENTILATOR WAS IMMEDIATELY REMOVED FROM SERVICE AND PT WAS PLACED ON A DIFFERENT AVEA VENTILATOR. NO ADVERSE OUTCOME TO THE PT." "BIOMEDICAL ENGINEERING RECEIVED THE VENTILATOR AND REPLACED THE BATTERY, CHARGED THE BATTERY AND THE VENTILATOR PASSED TESTING. THE VENTILATOR WAS PLACED BACK IN SERVICE. A BIOMED TECH RECENTLY ATTENDED SERVICE SCHOOL SPONSORED BY THE MANUFACTURER. THE MANUFACTURER SUGGESTED ADDING THE PROCEDURE OF TESTING AND CYCLING THE BATTERIES EVERY 180 DAYS. THIS WAS NOT BEING DONE EVERY 180 DAYS, AND SO THIS STEP WAS ADDED TO THE PREVENTIVE MAINTENANCE TASK LIST FOR THE VENTILATORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS 73CBK VENTILATOR, CONTINOUS (RESPIRATOR) CBK CAREFUSION 207, INC. AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other