BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-SCORT III

    MDR report key: 902276 · Received October 19, 2004

    Report

    Report Number
    2022724-2004-00001
    Event Type
    Malfunction
    Date Received
    October 19, 2004
    Date of Event
    September 21, 2004
    Report Date
    October 1, 2004
    Manufacturer
    SSCOR, INC.
    Product Code
    BTA
    Removal / Correction Number
    Z-050/58-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN JUNE 2000 SSCOR, INC. COMMENCED A VOLUNTARY RECALL (FIELD CORRECTION) OF ITS AFFECTED PORTABLE ASPIRATORS DUE TO SEVERAL FIELD COMPLAINTS IN REGARDS TO CRACKED IN-LINE FUSE HOLDERS. THE FIELD OFFICE OF THE FDA WAS NOTIFIED AND THEY ISSUED THE FOLLOWING NUMBER TO THIS VOLUNTARY RECALL. IN CONJUNCTION WITH THE VOLUNTARY RECALL, THE FOLLOWING MDR'S WERE ALSO ISSUED BY SSCOR, INC.: 2022724-2000-0001/0002/0003/0004/0005/0006/ AND 0008. SSCOR, INC. PERFORMED THE RECALL UNDER THE DIRECT GUIDANCE OF THE FDA AND THE FDA CLOSED THE RECALL, ON FEBRUARY 27, 2003. ALL DISTRIBUTORS, INCLUDING THE DISTRIBUTOR FOR THIS DEVICE, WERE NOTIFIED BY LETTER ON JUNE 28, 2000 OF SSCOR'S INTENTION TO CORRECT THIS MATTER.

    Description of Event or Problem · 1

    PARAMEDICS WERE CALLED TO ASSIST WITH A CARDIAC ARREST PATIENT. IT WAS THE PARAMEDICS JUDGEMENT THAT THE PATIENT WAS EXPIRED AT THE TIME THEY ARRIVED ON THE SCENE. FOLLOWING MANUAL PROCEDURE, THEY ATTEMPTED TO RESUSCITATE THE PATIENT. WHEN THEY WENT TO USE THE PORTABLE ASPIRATOR, THE UNIT DID NOT WORK. THE PARAMEDICS IMMEDIATELY USED ANOTHER SUCTION DEVICE TO CLEAR THE PATIENT'S AIRWAY. WHEN THEY RETURNED TO BASE, THE PARAMEDICS OPENED THE UNIT AND NOTICED THAT THE FUSE HOLDER WAS OPEN AND THE FUSE WAS MISSING. THE PARAMEDICS REPORT THAT THE SSCOR UNIT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-SCORT III PORTABLE POWERED ASPIRATOR BTA SSCOR, INC. 64000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR