BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ST RESPONSE MANUAL RESUSCITATOR, ADULT

    MDR report key: 159198 · Received March 20, 1998

    Report

    Report Number
    1044265-1998-00006
    Event Type
    Injury
    Date Received
    March 20, 1998
    Report Date
    March 20, 1998
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCLAIMER STATEMENT THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMINISTRATION BY SIMS PORTEX INC. PURSUANT TO 21 CFR PART 803, ND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS PORTEX INC. DEVICE HAS MALFUNCTIONED, NOT DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS PORTEX, INC. DEVICE AND A REPORTED DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE HOSP REPORTED TWO INCIDENTS WHERE THEY WENT TO USE THE SIMS RESUSCITATOR ON PTS AND FOUND THAT THE MASKS WERE MISSING FROM THE POLYBAG. ACCORDING TO THE HOSP, ONE INCIDENT THEY IMMEDIATELY REPLACED THE MASK AND CONTINUED THE CASE. THE OTHER INCIDENT THE PT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE. THE HOSP REPORTED THAT IN BOTH INCIDENTS THERE WAS NO HARM TO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE MANUAL RESUSCITATOR, ADULT MANUAL RESUSCITATOR, ADULT BTM SIMS PORTEX, INC. NA 7C0456

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN