BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL TEMPERATURE SKIN SENSOR

    MDR report key: 11855875 · Received May 20, 2021

    Report

    Report Number
    9613793-2021-00013
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 2, 2021
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FMT
    UDI-DI
    00749756671361
    PMA / PMN Number
    K200319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECTIVE SAMPLES WERE RECEIVED AT THE MANUFACTURING FACILITY, A FUNCTIONAL TEST (INVOLVEMENT OF THERMAL BATH TO OBTAIN RESULTS IN OHMS) WAS CONDUCTED TO ALL UNITS AND THE RESULTS OBTAINED WERE FOUND WITHIN THE TOLERANCE, NO ROOT CAUSE IS DETERMINED. PRODUCT IN PROCESS WERE SUBMITTED FOR A FUNCTIONAL TEST AND IT WAS CONFIRMED THAT ALL RESULTS WERE FOUND WITHIN SPECIFICATION. AN INVENTORY CHECK RELATED TO PRODUCT HNICU-37 HAD SEVEN CASES OF WORK ORDERS, THREE OF WHICH WERE RELATED TO THE LOT INVOLVING THE COMPLAINT. A VISUAL AND FUNCTIONAL INSPECTION WAS CONDUCTED. AFTER COMPLETION OF THE TESTS IT WAS CONFIRMED THAT ALL THE UNITS WERE FOUND WITHIN THE TOLERANCE. IN ADDITION, A VISUAL INSPECTION WAS PERFORMED TO 100% OF THE UNITS AND NO DISCREPANCIES WERE IDENTIFIED. COMPLAINT'S LOG OF THE LAST TWO YEARS CONFIRMED A TOTAL OF 18 COMPLAINTS GENERATED WITH THE SAME OR SIMILAR PART NUMBER, TWO OF THOSE CASES HAVE BEEN RELATED TO A SHIPPING ISSUE, IN TWO CASES IT HAS BEEN DETERMINED "USE ERROR" AS A ROOT CAUSE, FOR THE REST OF THE CASES, THE ROOT CAUSE HAS BEEN IDENTIFIED AS "UNDETERMINED"; THEREFORE, IT HAS BEEN CONFIRMED THAT NO ISSUES RELATED TO THE FUNCTIONALITY OF THE MEDICAL DEVICE HAVE BEEN DEMONSTRATED. DUE TO INCREASE IN NUMBER OF COMPLAINTS RELATED TO THE FUNCTIONALITY, A CORRECTIVE ACTION AN INTERNAL CORRECTIVE ACTION POINT HAS BEEN OPENED TO FULLY RESEARCH REPORTED ISSUES WITH THE PRODUCT. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    WORK ORDER INVOLVED WAS TRACED AND IT WAS CONFIRMED THAT THE FUNCTIONAL RESULTS WERE REVIEWED. IT WAS CONFIRMED THAT ALL RESULTS WERE FOUND WITHIN THE SPECIFICATION. WE ARE STILL WAITING FOR PRODUCT TO BE RETURNED TO PERFORM FUNCTIONAL INSPECTION. THE INVESTIGATION IS INCOMPLETE AT THIS TIME, A FOLLOW-UP WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SEVERAL BABIES GOT COLD WHILE USING PROBE, ANOTHER PROBE WAS USED; HOWEVER, IT DID NOT REGISTER TEMPERATURE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752447 NEONATAL TEMPERATURE SKIN SENSOR INFANT RADIANT WARMER FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU-37 00749756671361

    Patients

    Seq Age Sex Outcome Treatment
    1