BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL SKIN TEMPERATURE PROBE

    MDR report key: 7052600 · Received November 22, 2017

    Report

    Report Number
    9613793-2017-00005
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 22, 2017
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    FMT
    PMA / PMN Number
    K925006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY. AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT A NEONATAL TEMPERATURE PROBE (PART NUMBER HNICU-37, LOT 43991730) FAILED DURING USE. A SAMPLE WAS REPORTED TO BE AVAILABLE FOR EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE SAMPLES HAVE NOT BEEN RETURNED TO THE MANUFACTURING FACILITY. WHEN THE SAMPLES HAVE BEEN RECEIVED AND EVALUATED, THIS REPORT WILL BE UPDATED. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE SUB-ASSEMBLY WORK ORDER ALSO WAS REVIEWED AND ALL FUNCTIONAL RESULTS WERE WITHIN SPECIFICATIONS. A TWO-YEAR REVIEW OF COMPLAINTS SHOWED NO SIMILAR ISSUES FOR THE REPORTED LOT NUMBER. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN AT THIS TIME. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE END USER REPORTED CONCERNS WITH THE ABILITY OF A NEONATAL TEMPERATURE PROBE TO READ THE BABY'S TEMPERATURE. DURING USE, SOME PROBES WERE REPORTED TO NOT SHOW AN ACCURATE TEMPERATURE OR FLUCTUATING TEMPERATURE READINGS OR NOT SHOW A READING AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831690 NEONATAL SKIN TEMPERATURE PROBE WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. HNICU-37 43991730

    Patients

    Seq Age Sex Outcome Treatment
    1