BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1893827 · Received November 1, 2010

    Report

    Report Number
    2021710-2010-00052
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K051226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4): THE CAREFUSION TECH SUPPORT SPECIALIST ADVISED THE USER FACILITY REP THAT THE DEVICE'S MAIN BOARD WOULD NEED TO BE REPLACED IN ORDER TO REPAIR THE DEVICE. THE USER FACILITY REP WAS PROVIDED THE PART NUMBER AND COST OF THE MAIN BOARD ALONG WITH THE LABOR COSTS THAT WOULD BE ASSOCIATED WITH HAVING THE DEVICE REPAIRED BY THE CAREFUSION FACTORY SERVICE DEPT. THE USER FACILITY REP INDICATED THAT THEY WILL DECIDE WHETHER THEY WANT TO SEND THE DEVICE IN OR ORDER THE MAIN BOARD AND INSTALL IT THEMSELVES. THE FOLLOWING INFO CONCERNING THE EVAL AND REPAIR OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "I SPOKE TO (NAME REMOVED). HE STATED THAT HE NEVER ENDED UP PURCHASING A BOARD. HE STATED THAT HE GOT THE PN OFF OF THE SPEAKER ON THE BOARD AND ORDERED THAT EXACT ONE AND SOLDERED IT ON THERE HIMSELF. HE SAID IT WORKS FINE NOW AND IS BACK IN SERVICE. HE REALIZES THIS IS SOMETHING WE DIDN'T RECOMMEND DOING ETC. TOLD HIM WE WILL NOTE THIS IN CALL. HE UNDERSTOOD." A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM DID NOT FIND ANY COMPONENT OR SYSTEM TREND. AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "(NAME REMOVED) IN BIOMED CALLED AND SAID THAT THIS UNIT WILL ACTIVATE THE LED FOR AN ALARM BUT, IT WON'T AUDIBLY ALARM. NO PT INVOLVEMENT. HE ASKED IF HE CAN JUST GET THE ALARM ITSELF OR DOES HE HAVE TO REPLACE THE MAIN BOARD. EXPLAINED TO HIM THAT THE MAIN BOARD WOULD NEED TO BE REPLACED. GAVE HIM PN 003-007017, 915.68. HE ASKED IF THE FACTORY HAD A FLAT RATE. EXPLAINED TO HIM THAT IT WOULD BE THE PRICE OF THE PART PLUS AT LEAST 2 HRS OF LABOR AT 165/HR. HE WILL FIND OUT IF THEY WANT TO SEND IT IN OR JUST WANT TO ORDER THE PART AND CALL BACK. EXPLAINED TO HIM THAT THIS PART IS ORDERED THROUGH TECH SUPPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH VENTILATOR, NON-CONTINUOUS (RESPIRATOR) / BZD BZD CAREFUSION AIRLIFE NCPAP DRIVER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA