BEUDAMED
    FDA Adverse Event Death Summary report: N

    SSCOR

    MDR report key: 6851973 · Received September 8, 2017

    Report

    Report Number
    2022724-2017-00002
    Event Type
    Death
    Date Received
    September 8, 2017
    Date of Event
    April 19, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SSCOR, INC
    Product Code
    BTA
    PMA / PMN Number
    K945929
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 SSCOR RECEIVED AN EMAIL FROM (B)(6), (B)(6) OF (B)(6) EMS. THE EMAIL INDICATED IN THE PAST WEEK THE DEPARTMENT HAD TWO SSCOR VX-2 (MODEL 2310BV) SUCTION UNITS STOP WORKING DURING PATIENT CARE SITUATIONS. AFTER THE EMAIL WAS RECEIVED SSCOR FOLLOWED UP WITH (B)(6) TO GATHER ADDITIONAL INFORMATION. THE INITIAL INDICATIONS WERE THE DEVICE STOPPED WORKING BECAUSE THE INTERNAL BATTERY IN THE SUCTION DEVICE HAD LOST CAPACITY. SSCOR REQUESTED THE DEPARTMENT CHECK ALL OF THE BATTERIES IN THEIR DEVICES BY CONDUCTING THE BATTERY TEST AS DESCRIBED IN THE INSTRUCTIONS FOR USE FOR THE DEVICES. ADDITIONALLY, SSCOR SENT OUT A TOTAL OF (B)(4) NEW REPLACEMENT BATTERIES FOR ALL THE SSCOR SUCTION UNITS OWNED BY THE DEPARTMENT AS A PRECAUTIONARY MEASURE. ON (B)(6) 2017 THE DEPARTMENT REPORTED THEY FOUND THAT (B)(4) OF THE DEVICES HAD BATTERIES WITH LOW CAPACITY. THEY WERE ABLE TO REPLACE THESE LOW CAPACITY BATTERIES WITH THE REPLACEMENT BATTERIES SSCOR SENT OUT. SSCOR ALSO DISCUSSED THE BATTERY CARE AND MAINTENANCE PROCEDURES AS DESCRIBED IN THE OPERATIONS MANUAL WITH THE DEPARTMENT. THE DEPARTMENT WAS NOT FOLLOWING THE RECOMMENDED BATTERY MAINTENANCE PROCEDURES. AFTER THE DISCUSSION THE DEPARTMENT AGREED TO UPDATE THEIR INTERNAL PROTOCOLS AND FOLLOW THE BATTERY CARE AND MAINTENANCE PROCEDURES AS DESCRIBED IN THE OPERATIONS MANUAL FOR THE DEVICES.

    Description of Event or Problem · 1

    PARAMEDICS WERE CALLED TO AID A PATIENT WITH BREATHING PROBLEMS. THE PARAMEDICS ARRIVED TO FIND THE PATIENT UNRESPONSIVE, PULSE-LESS AND APNEIC. ADDITIONALLY THE PATIENTS PUPILS WERE FIXED AND NON-REACTIVE AND MOTOR SKILLS WERE FOUND TO BE FLACCID. THE PARAMEDICS INITIATED CPR ACTIVITIES AND ATTEMPTED TO SUCTION THE PATIENT AT THE SCENE USING A SSCOR SUCTION DEVICE. THE DEVICE WOULD NOT OPERATE AT THAT TIME. THE PATIENT WAS TRANSPORTED TO THE VEHICLE AND THE SUCTION UNIT WAS INSTALLED INTO ITS CHARGING / RETENTION BRACKET AT WHICH TIME THE DEVICE OPERATED TO SPECIFICATIONS AS IT WAS BEING POWERED BY THE VEHICLE BATTERY. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631226 SSCOR VX-2 BTA SSCOR, INC 2310BV N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death