BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5415198 · Received February 6, 2016

    Report

    Report Number
    2021710-2016-02910
    Event Type
    Malfunction
    Date Received
    February 6, 2016
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. THE UNIT WAS RETURNED TO CAREFUSION FOR EVALUATION AND REPAIR. THE ISSUE WAS ISOLATED TO A DEFECTIVE ALARM PCBA, PN 771401, SN (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN A RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE ON (B)(6) 2014. THE CUSTOMER CALLED TO REPORT THAT THE BATTERY LOW LIGHT IS ON EVEN WITH A GOOD BATTERY AND THE OVERHEAT LIGHT IS ON. THEY DID A PERFORMANCE CHECK AND THE AMPS ARE LOW AT 76CM. THE DRIVER OVERHEAT LIGHT WENT ON AFTER A FEW MINS ON THE PERFORMANCE CHECK SETTINGS. THERE WAS NO PATIENT INVOLVEMENT IN THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73381 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1