BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL TEMP PUMP PROFESSIONAL

    MDR report key: 3864170 · Received June 10, 2014

    Report

    Report Number
    0001831750-2014-03054
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE MOTOR AND MOUNTING PLATE AND RETURNING THE UNIT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT FAILED THE GROUND RESISTANCE PORTION OF THE FUNCTIONAL TESTING. THE UNIT WAS REPLACED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT FAILED THE GROUND RESISTANCE PORTION OF THE FUNCTIONAL TESTING. THE UNIT WAS REPLACED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338438 CAPITAL TEMP PUMP PROFESSIONAL PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1