BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCM COMBIM

    MDR report key: 5061907 · Received September 4, 2015

    Report

    Report Number
    3002807968-2015-00022
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 10, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K093154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS TAKEN TO RADIOMETERS WORKSHOP AND IT WAS UPGRADED WITH A NEWER PC/MOTHER BOARD, COMBIM MODUL 903-111, AND A NEW CF CARD 933-269. THE ERROR DID NOT APPEAR AFTER REPLACEMENT OF ABOVE NAMED PARTS AND THE ANALYZER HAS BEEN SHIPPED BACK TO THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    NOT FEI BASED: THE MDR REPORT FOR THIS CASE IS NOT FEI BASED FOR FOLLOW UP REPORT NO. 1. THE MDR REPORT NO. WAS MISSING THE DIGITS 968 AND STATED TO BE 3002807-2015-00022 INSTEAD OF 3002807968-2015-00022. DATE OF THIS REPORT: WAS LEFT BLANK IN FOLLOW UP 1 (10/06/2015).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE VOLUME OF THE ALARM SIGNAL IS SIGNIFICANTLY HIGHER THAN THE SPECIFIED HIGHEST POSSIBLE LEVEL. ACCORDING TO THE INSTRUCTIONS FOR USE, THE ALARM SOUND PRESSURE AT THE HIGHEST ALARM SOUND LEVEL IS 83 DBA. THE MONITOR IS PLACED IN A NEONATAL WARD AND THE CUSTOMER IS CONCERNED THAT NOISE LOAD CAN LEAD TO STRESS AND EVEN TO DAMAGE TO THEIR PREMATURE INFANT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587474 TCM COMBIM LKD RADIOMETER MEDICAL APS 903-111

    Patients

    Seq Age Sex Outcome Treatment
    1