BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL TEMP PUMP PROFESSIONAL

    MDR report key: 3955031 · Received July 24, 2014

    Report

    Report Number
    0001831750-2014-03178
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 22, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REPLACED FOR THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE UNIT WOULD NOT HEAT. A NON-FUNCTIONING HEATER WOULD CAUSE THE DEVICE TO NOT DELIVER WATER ACCORDING TO TEMPERATURE SETTING. AN ALTERNATIVE DEVICE COULD BE USED FOR TEMPERATURE THERAPY. 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 BY SERVICE REPORT THAT THE UNIT FAILED THE OVERHEAT TEST. 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 BY SERVICE REPORT THAT THE UNIT FAILED THE OVERHEAT TEST. 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
    433996 CAPITAL TEMP PUMP PROFESSIONAL PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1