BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIRD

    MDR report key: 1358832 · Received March 24, 2009

    Report

    Report Number
    2021710-2009-00009
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    February 13, 2009
    Report Date
    March 24, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "BIOMED REVIEW ON 02/16/2009: VISUAL INSPECTION REVEALED MELTED PT CIRCUIT." THE BIRD VIP GOLD VENTILATOR DID NOT FAIL, IT OPERATED AS INTENDED. THE DEVICE WAS RECEIVED INTO THE CARDINAL HEALTH FAILURE ANALYSIS LAB AND IS AWAITING EVALUATION. ONCE THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS COMPLETE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH FROM THE FDA ON 02/23/2009. "EVENT DESC: BABY ON CPAP VIA NASAL PRONGS WITH 40% OXYGEN DELIVERY VIA THE VENTILATOR. CIRCUIT HAD BEEN CHANGED PER PROTOCOL 30 MINUTES BEFORE EVENT. SMOKE ALARM WENT OFF AND RN NOTED FLAMES SHOOTING FROM THE HEATER ON THE VENT. SHE IMMEDIATELY RESCUED INFANT AND LEFT ROOM. FIRE EXTINGUISHED PER HOSPITAL STAFF." THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "(RESP CARE MANAGER) CALLED ME. REPORTS THAT THE VIP GOLD VENTILATOR SUFFERED MINOR SMOKE DAMAGE, BUT WELCOMES THE IDEA OF HAVING A SERVICE CALL. HE EXPLAINS THAT THEY KNOW FOR SURE THAT THE VIP VENTILATOR WAS NOT AT FAULT. THERE IS AN INVESTIGATION AS TO THE REASON THE CIRCUIT CAUGHT FIRE. AGREES TO BE THE CONTACT PERSON AND UNDERSTANDS THIS EVAL WILL BE AT "NO CHARGE". I'LL DISPATCH AND PLACE IN THE QUEUE. (THE VENT IS IN THE BIOMED SHOP)". "FIELD SERVICE WANTS TO HAVE THIS UNIT COME BACK FOR REPAIRS, I HAVE CONTACTED THE CUSTOMER AND IS OK WITH HIM TO SHIP IT BACK TO OUR SERVICE DEPT." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS COPIED FROM A LETTER RECEIVED FROM THE USER FACILITY ON 03/09/2009 THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFORMATION. "FIRE BROKE OUT 30 MINUTES - AFTER CIRCUIT FOR CPAP CHANGED. LATER DETERMINED CIRCUIT TO BE 22 VOLTS - HEATER IS 28 VOLTS. SMOKE ALARM IN ROOM SOUNDED. VENTILATOR DID NOT ALARM." "NO HARM TO INFANT FROM EVENT. CONTINUED CPAP SUPPORT. REMAINS IN NICU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD 73CBK VENTILATOR, CONTINUOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. VIP GOLD

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other PULSE OXIMETER| SCT 3000| INFANT INCUBATOR - GE GIRAFFE OMNIBED| EVALUEMED PLUS| HUMIDIFIER HEATER - MARQUEST| BIRD VIP GOLD| CARDIAC MONITOR| BAXTER IV PUMP