BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN TEMPERATURE PROBE

    MDR report key: 6959280 · Received October 18, 2017

    Report

    Report Number
    9613793-2017-00002
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 1, 2017
    Report Date
    February 8, 2018
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    FMT
    PMA / PMN Number
    K925006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A ROOT CAUSE COULD NOT BE IDENTIFIED BECAUSE NO DISCREPANCIES WERE FOUND WITH THE DEFECTIVE SAMPLE OR IN THE DOCUMENTATION ON HAND. CORRECTIVE ACTION: A CORRECTIVE ACTION WAS NOT TAKEN DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED REPORTING THAT AN ADULT SKIN TEMPERATURE PROBE (PART NUMBER V81-010400) DETECTED A TEMPERATURE READING DURING USE ON A POST-OPERATIVE PATIENT. A SAMPLE WAS REPORTED TO BE AVAILABLE FOR EVALUATION. THE SAMPLE WAS RECEIVED AND EVALUATED. A FUNCTIONAL TEST WAS PERFORMED ON THE DEVICE BY ITSELF AS WELL AS WITH AN INTERFACE CABLE. THE RESULTS WERE WITHIN THE DEVICE SPECIFICATION OF 1344-1366 OHM. THE FUNCTIONAL TESTS CONFIRMED THAT THERE WERE NO DISCREPANCIES WITH THE DEFECTIVE SAMPLE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED. NO ISSUES WERE REPORTED DURING THE MANUFACTURING PROCESS. THE SUB-ASSEMBLY WORK ORDERS ALSO WERE REVIEWED; NO FUNCTIONAL ISSUES WERE IDENTIFIED. AN INVENTORY CHECK OF THE WORK ORDER IN PROCESS ALSO WAS CONDUCTED. NO FUNCTIONAL ISSUES WERE IDENTIFIED. A TWO-YEAR REVIEW OF COMPLAINTS WAS COMPLETED AND THREE SIMILAR COMPLAINTS WERE IDENTIFIED. THESE COMPLAINTS WERE FOR A DIFFERENT PART NUMBER AND HAVE BEEN CLOSED AND VERIFIED. A TWO-YEAR REVIEW OF MATERIAL REVIEW REPORTS (MRR) ALSO WAS CONDUCTED. MRRS THAT HAVE BEEN GENERATED DUE TO FUNCTIONALITY ISSUES DURING THE MANUFACTURING PROCESS WERE IDENTIFIED. HOWEVER, AT THIS TIME, ALL REPORTS HAVE BEEN PROPERLY CLOSED AND VERIFIED. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY. AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED REPORTING THAT AN ADULT SKIN TEMPERATURE PROBE (PART NUMBER (B)(6)) DETECTED A TEMPERATURE READING DURING USE ON A POST-OPERATIVE PATIENT. A SAMPLE WAS REPORTED TO BE AVAILABLE FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAD NOT BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT'S POST-OP TEMPERATURE WAS READING VERY LOW. A BAIR HUGGER WAS IN USE READING 36 DEGREES AND THE ADULT SKIN TEMPERATURE PROBE WAS READING 32 DEGREES. THE SKIN TEMPERATURE PROBE WAS PLACED ON THE BACK.

    Description of Event or Problem · 1

    THE PATIENT'S POST-OP TEMPERATURE WAS READING VERY LOW. A BAIR HUGGER WAS IN USE READING 36 DEGREES AND THE ADULT SKIN TEMPERATURE PROBE WAS READING 32 DEGREES. THE SKIN TEMPERATURE PROBE WAS PLACED ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739182 SKIN TEMPERATURE PROBE WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. V81-010400 45042301

    Patients

    Seq Age Sex Outcome Treatment
    1