BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERSCREEN IOS

    MDR report key: 5540136 · Received March 31, 2016

    Report

    Report Number
    9615102-2016-00001
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZG
    PMA / PMN Number
    K101873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO A RETROSPECTIVE COMPLAINT REVIEW PERFORMED BY CAREFUSION. THE CAREFUSION IDENTIFICATION FILE IS (B)(4). A CAREFUSION FIELD SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER'S FACILITY AND FOUND THE SCREWS HAD BEEN STRIPPED. THE SCREWS WERE REPLACED AND THE ARM IS NOW FUNCTIONING AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CAREFUSION FIELD SERVICE ENGINEER THAT THE CUSTOMER STATED THE ARM HOLDING THE IMPULSE OSCILLOMETER (IOS) HEAD BECAME DISCONNECTED FROM THE CART AND FELL ONTO THE PATIENT'S LAP DURING TESTING. THE PATIENT WAS A LARGE MALE AND HE CAUGHT THE IOS/ARM ASSEMBLY. THERE WAS NO HARM DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195559 MASTERSCREEN IOS SPIROMETER, DIAGNOSTIC BZG CAREFUSION, INC MASTERSCREEN IOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other