BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 1810811 · Received August 17, 2010

    Report

    Report Number
    1310379-2010-00013
    Event Type
    Other
    Date Received
    August 17, 2010
    Report Date
    July 30, 2010
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010, THAT A CUSTOMER HAD AN ISSUE WITH AN SCD COMPRESSION SYSTEM. THE CUSTOMER REPORTS DURING A PROCEDURE IN WHICH THE PATIENT WAS WEARING SCD COMPRESSION SLEEVES, THE PATIENT SUFFERED AN INTRAOPERATIVE MYOCARDIAL INFARCTION (MI). THE BIOMED DEPARTMENT OF THE HOSPITAL DID A ROUTINE CHECK OF PUMP AND FOUND NOTHING WRONG; HOWEVER, THEY WANT EVALUATION BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS COMPRESSION SYSTEM SEQUENTIAL COMPRESSON SYSTEM JOW COVIDIEN 9525 V0751361

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening