BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-PROBE

    MDR report key: 2217143 · Received July 15, 2011

    Report

    Report Number
    1516825-2011-00010
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    BZT
    PMA / PMN Number
    K072621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELATED COMPLAINT (B)(4) WAS RECEIVED ON (B)(4) 2011 AND WAS IDENTIFIED AS NON-REPORTABLE. HOWEVER, UPON RECEIVING USER FACILITY REPORT, WE DECIDED TO REPORT THE EVENT IN RESPONSE TO THE USER FACILITY REPORT RECEIVED FROM FDA ON (B)(4) 2011. THE PROBE LOT NUMBER (D722015) WAS TRACED BACK TO ALPHA SENSORS, INC AS THE MFR. OUR INVESTIGATION SHOWS THAT WHEN WE MOVED THE PROBE SLIGHTLY FROM SIDE TO SIDE, THE PT TEMP DISPLAY BECAME ERRATIC AND WOULD NOT MAINTAIN A CONSTANT READING. ONCE MOVEMENT OF THE PROBE STOPPED, THE PT TEMP READING AGAIN RESPONDED AS EXPECTED. THE FAILURE MODE WAS CONFIRMED SIMILAR TO ONE EXPERIENCED BY THE PROBES IN THE PAST. THE PROBE HAD AN INTERMITTENT CONNECTION AT THE RJ-LL CONNECTOR DUE TO A MFG DEFECT BY ALPHA SENSORS, INC. CSZ MADE THESE PROBES OBSOLETE IN (B)(4) 2009 AND HAS SCRAPPED ALL PROBES IN STOCK. CSZ IS NO LONGER A MFR OF TEMP PROBES, HOWEVER, CSZ DISTRIBUTES TEMP PROBES MANUFACTURED BY MEASUREMENT SPECIALTIES. IN (B)(4) 2009, CSZ IMPLEMENTED A CORRECTION THAT WAS COMMUNICATED TO THE CUSTOMER WHO HAVE FILED A COMPLAINT AND TO WHOM WHO HAVE ORDERED NEW TEMP PROBES. CSZ IS REVIEWING FOR FIELD REPLACEMENT WHERE SUSPECT LOT NUMBER DEVICES HAVE BEEN SHIPPED PRIOR TO 2009. AS SOON AS THE RECALL DECISION IS MADE, FDA WILL BE NOTIFIED.

    Description of Event or Problem · 1

    THE PT WAS ON TOTAL BODY COOLING AND DURING THE COURSE OF HER THREE DAY COOLING THE MACHINE SHUT OFF THREE TIMES AND ALARMED "CHECK PROBE". THE NURSE WAS ABLE TO RE-START THE MACHINE WITHOUT DIFFICULTY THE FIRST THREE TIMES. THE FOURTH TIME THE MACHINE SHUT OFF AT APPROX 48 HOURS INTO COOLING AND ALARMED "CHECK PROBE". I WAS CONTACTED BY THE NURSE CARING FOR THE PT AFTER SHE COULD NOT GET THE MACHINE TO RESTART. I ADVISED HER TO REPLACE THE PROBE, WHICH SHE DID. NO FURTHER CONCERNS WERE EXPERIENCED. THE PROBE WAS NOT CHANGED AFTER THE FIRST THREE ALARMS BECAUSE THE MACHINE WAS EASILY RE-STARTED AND TO MINIMIZE THE DISCOMFORT TO THE PT. COOLING SHOULD NOT BE INTERRUPTED FOR MORE THAN 30 MINS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-PROBE RECTAL/ESOPHAGEAL TEMPERATURE PROBE BZT CINCINNATI SUB-ZERO PRODUCTS, INC. 491B D722015

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other