BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-PROBE

    MDR report key: 2181534 · Received July 25, 2011

    Report

    Report Number
    2181534
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    CINCINNATI SUB-ZERO
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE MACHINE ALARMED "CHECK PROBE" TWICE. AFTER RESTARTING IT, THE PATIENT'S TEMPERATURES WERE ASSESSED AND IT WAS NOTED THAT THE PATIENT'S TEMPERATURES WERE FLUCTUATING IN A WIDE RANGE FROM 31.1 TO 33.7. THE SET POINT ON THE MACHINE WAS 33.5 AND THE GOAL IS TO BE WITHIN 1 DEGREE OF THIS. IT WAS DECIDED AT THIS TIME, BECAUSE OF THE RANGE IN TEMPERATURES, TO CHANGE THE PROBE. THIS WAS ACCOMPLISHED WITHOUT DIFFICULTY AND THERE WERE SUBSEQUENTLY NO FURTHER ALARMS OR EXTREME VARIANCE IN TEMPERATURES. TEMPERATURES WERE 32.6-33.7 IN THE NEXT 24 HOURS. THE COMPANY WAS CONTACTED AND THE COMPANY REPORTED THAT THE PROBE WAS EXPIRED. AFTER CHECKING THE PACKAGING ON THE REMAINING OLDER PROBES, THERE IS NO EXPIRATION DATE IDENTIFIED ON THE PACKAGING OR THE BOX. SEE PREVIOUS REPORT. THIS IS THE SAME COMPANY, SIMILAR CIRCUMSTANCE, BUT WITHOUT THE TEMPERATURE VARIANCE.======================MANUFACTURER RESPONSE FOR RECTAL/ESOPHAGEAL TEMPERATURE PROBE, STERI-PROBE (PER SITE REPORTER)======================THE MANUFACTURER WANTS ALL THESE OLDER PROBES RETURNED TO THEM IN ADDITION TO THE PROBE IN QUESTION AS THEY HAVE INDICATED THAT THEY ARE EXPIRED. THE PACKAGING DID NOT SPECIFY AN EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-PROBE RECTAL/ESOPHAGEAL TEMPERATURE PROBE FLL CINCINNATI SUB-ZERO * D527632

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY NO OTHER THERAPIES