BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 8663174 · Received June 3, 2019

    Report

    Report Number
    3002637618-2019-00065
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 11, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    UDI-DI
    00630414574639
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS TECH OPS HAS COMPLETED THE INVESTIGATION. THE FAILED BATTERY CAUSING THE BATTERY HOLDER TO MELT WAS THE SOURCE OF THE BURNING SMELL, BUT IS NOT A FIRE RISK. THIS FAILURE COULD HAVE OCCURRED DUE TO THE USE OF INCORRECT, EXPIRED OR RECHARGEABLE BATTERIES. IT IS SPECIFIED THAT THE STATUS SHALL BE USED WITH COMMON 1.5V AA BATTERIES. BATTERIES OUTSIDE OF THE SPECIFIED TYPE CAN BE SUSCEPTIBLE TO THERMAL RUNAWAY, CAUSING THE BATTERY TO GENERATE EXCESS HEAT EVENTUALLY RESULTING IN THE MELTING OF THE SURROUNDING PLASTIC. THE CUSTOMER STATED THAT THEY ARE FULLY FUNCTIONAL, AND THE UNIT IS BACK IN SERVICE.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND BATTERIES HAVE BEEN REQUESTED FOR INVESTIGATION. A NEW INSTRUMENT HAS BEEN SENT TO THE CUSTOMER. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ DID NOT POWER ON. SIEMENS SERVICE INSTRUCTED THE CUSTOMER TO UNPLUG THE UNIT AND INSTALL NEW BATTERIES. ONCE THE BATTERIES WERE INSTALLED, THE CUSTOMER ATTEMPTED TO TURN THE UNIT ON AND THEN SMELLED SMOKE. WHILE REMOVING THE BATTERIES THE CUSTOMER NOTICED SMOKE COMING FROM THE BATTERIES. SERVICE WAS NOT ABLE TO DETERMINE IF THE BATTERIES WERE INSTALLED PROPERLY AND HAD THE CUSTOMER REMOVE THE BATTERIES. A NEW CLINITEK STATUS+ WILL BE PROVIDED TO THE CUSTOMER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455130 CLINITEK STATUS+ CLINITEK STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS 00630414574639

    Patients

    Seq Age Sex Outcome Treatment
    1