BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 4209370 · Received September 19, 2014

    Report

    Report Number
    2021710-2014-00053
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE FOREIGN DISTRIBUTOR. (B)(4). THE FOREIGN DISTRIBUTOR EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED EVENT WAS ASSOCIATED WITH THE ALARM BOARD ASSEMBLY. THE FOREIGN DISTRIBUTOR REPAIRED THE DEVICE BY REPLACING THE ALARM BOARD ASSEMBLY WITH ONE FROM THEIR STOCK. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY ALARM BOARD ASSEMBLY FOR EVAL. AS OF SEPTEMBER 18, 2014 THE ALLEGED FAULTY ALARM BOARD ASSEMBLY HAS NOT BEEN RECEIVED. SHOULD THE ALARM BOARD ASSEMBLY RETURN FOR EVAL, A F/U MEDWATCH REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A WARRANTY CLAIM FORM SUBMITTED BY THE FOREIGN DISTRIBUTOR. "OSCILLATOR TMA 31715 AT GSH HAS NO AUDIBLE ALARM EXCEPT FOR POWER FAILURE. THIS FAULT WAS DISCOVERED DURING A2000HR CALIBRATION. WAS PRODUCT ON PT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584583 SENSORMEDICS VENITILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA