BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S.SCORT DUET

    MDR report key: 195165 · Received October 30, 1998

    Report

    Report Number
    2022724-1998-00004
    Event Type
    Malfunction
    Date Received
    October 30, 1998
    Date of Event
    September 10, 1998
    Report Date
    October 28, 1998
    Manufacturer
    SSCOR, INC.
    Product Code
    BTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 10, 1998 SSCOR, INC REC'D A S-SCORT DUET ASPIRATOR, MODEL #2014 FOR REPAIR. A SSCOR TECHNICIAN EVALUATED THE UNIT. THE UNIT WAS FOUND TO HAVE A NON-FUNCTIONAL THOMAS, IND PUMP. THE THOMAS, IND PUMP WAS DISSECTED AND EVALUATED BY THE SSCOR REPAIR DEPT. THE PUMP WAS FOUND TO HAVE A BROKEN ECCENTRIC ASSEMBLY. SUBSEQUENT TO THE PUMP EVAL SSCOR CONTACTED THE OWNER OF THE ASPIRATOR. THE BIOMEDICAL DEPT OF THE HOSP ORIGINALLY HANDLED THE ASPIRATOR AND SENT IT BACK FOR REPAIR. BIOMED EXPLAINED THAT THE ASPIRATOR WAS REC'D AND SHELVED FOR ABOUT A WEEK. UPON REMOVAL FROM PACKAGING THE ASPIRATOR WAS FOUND TO HAVE WEAK SUCTION AND A HIGH NOISE LEVEL. BIOMED SENT THE ASPIRATOR BACK FOR REPAIR OR REPLACEMENT. THE ASPIRATOR WAS NEVER PUT INTO ACTIVE SVC THUS IT WAS NEVER USED ON OR AROUND PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.SCORT DUET BATTERY OPERATED PORTABLE SUCTION PUMP BTA SSCOR, INC. S.SCORT DUET NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other