BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-PROBE

    MDR report key: 2238408 · Received August 12, 2011

    Report

    Report Number
    1516825-2011-00011
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    BZT
    PMA / PMN Number
    K072621
    Removal / Correction Number
    CSZ FA2011-009
    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, FOLLOWED BY A USER FACILITY REPORT, WHICH WE RECEIVED ON (B)(4) 2011. THE PROBE LOT NUMBER ((B)(4)) WAS TRACED BACK TO ALPHA SENSORS, INC AS THE MFR. THE INVESTIGATION OF A SIMILAR PROBE SHOWED THAT WHEN WE MOVED THE PROBE SLIGHTLY FROM SIDE TO SIDE, THE PT TEMPERATURE DISPLAY BECAME ERRATIC AND WOULD NOT MAINTAIN A CONSTANT READING. ONCE MOVEMENT OF THE PROBE STOPPED, THE PT TEMPERATURE READING AGAIN RESPONDED AS EXPECTED. THE FAILURE MODE SEEMED TO BE CONFIRMED AS SIMILAR TO ONE EXPERIENCED BY THE PROBES IN THE PAST. THE PROBE HAD AN INTERMITTENT CONNECTION AT THE RJ-11 CONNECTION 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 TEMPERATURE PROBES, HOWEVER, CSZ DISTRIBUTES TEMPERATURE PROBES MFG BY MEASUREMENT SPECIALTIES. IN (B)(4) 2009, CSZ IMPLEMENTED A CORRECTION THAT WAS COMMUNICATED TO THE CUSTOMER WHO FILED A COMPLAINT AND TO WHOM HAS ORDERED NEW TEMPERATURE PROBES. CSZ HAS PERFORMED HEALTH HAZARD EVAL AND MADE A DECISION TO RECALL THESE PROBES. CSZ WILL WORK WITH FDA DISTRICT RECALL COORD AND INITIATE A RECALL AS SOON AS POSSIBLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED "WE HAVE HAD ANOTHER PROBE ISSUE. THIS ONE WAS A BIT DIFFERENT. THE MACHINE ALARMED TWICE FOR THE PROBE ("CHECK PROBE") AND WAS EASILY RESET. THE THING WE DID NOTICE WAS THAT THE BABY'S TEMP WAS MIGRATING A GREAT DEAL FROM 31.1-33.7. THE 31.1 IS MUCH TOO LOW. BECAUSE OF THIS, WE WENT AHEAD AND CHANGED THE PROBE WHEN WE HAD THE SECOND ALARM EVEN THOUGH IT RESET WITHOUT TROUBLE. AFTER THE PROBE CHANGE, THE TEMPERATURES STABILIZED BETWEEN 32.6 AND 33.7 AS OF THIS AM." THE CUSTOMER WENT ON TO SAY THAT THEY WILL BE ADDING THIS TO THEIR MEDSUN (FDA) REPORT. (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 D527632

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other