BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 18715064 · Received February 15, 2024

    Report

    Report Number
    2022724-2024-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 14, 2024
    Manufacturer
    SSCOR INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR REACHED OUT TO CUSTOMER TO RECEIVE ADDITIONAL INFORMATION. REPORTER REFUSED TO PROVIDE PATIENT INFORMATION DUE TO PATIENT PRIVACY REGULATIONS. REPORTER STATED THAT THEY WERE TRANSPORTING A PATIENT FROM ONE BUILDING TO AN ADJACENT BUILDING, A FEW MINUTES INTO THE CALL DEVICE SN (B)(6)FAILED. THEY TRIED THEIR BACK UP DEVICE SN (B)(6) AND THAT DEVICE FAILED AS WELL. THEY TRIED TWO MORE DEVICES SN (B)(6) AND (B)(6) AND THOSE DEVICES FAILED AS WELL. THEY WERE ABLE TO TRY A FIFTH DEVICE AND CLEARED THE PATIENT'S AIRWAY, REPORTER STATED THAT THEY HAD PURCHASED (B)(4) BACK IN 2020 AND HAVE HAD ISSUES WITH THE MAJORITY OF BATTERIES PURCHASED. SSCOR REQUESTED FOR REPORTER TO SEND LOT NUMBER AND PICTURES OF THE NON-CONFORMING BATTERIES. PICTURES AND LOT NUMBERS CONFIRMED THAT BATTERIES USED IN DEVICES WERE NOT SSCOR BATTERIES THEY WERE THIRD PARTY BATTERIES. SSCOR RECOMMENDS THAT BATTERIES BE REPLACED EVERY THREE YEARS. CONTRARY TO MANUFACTURER RECOMMENDATIONS BATTERIES PURCHASED BACK IN 2020 WERE INSTALLED PAST MANUFACTURERS RECOMMENDATIONS. SSCOR ADVISED REPORTER THAT BATTERIES CAUSING DEVICE TO FAIL WERE NOT SSCOR BATTERIES AND SHOULD REPLACE ALL BATTERIES IN THEIR DEVICES AS SOON AS POSSIBLE TO PREVENT FUTURE MALFUNCTIONS. SSCOR HAS ADVISED REPORTER TO ADHERE TO BATTERY MAINTENANCE AS INSTRUCTED PER DEVICE INSTRUCTIONS MANUAL. SSCOR RECOMMENDED REPORTER THEY USE SSCOR BATTERIES AND A QUOTE FOR REPLACEMENT BATTERIES WAS PROVIDED TO THEIR PURCHASING DEPARTMENT. AT THE TIME OF THIS REPORT ORDER FOR REPLACEMENT BATTERIES HAS NOT YET BEEN PLACED.

    Description of Event or Problem · 0

    DEVICE HAD SHORT BATTERY LIFE DURING PATIENT TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669277 SSCOR INC SSCOR DUET BTA SSCOR INC. 2314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown