BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECA

    MDR report key: 16746934 · Received April 14, 2023

    Report

    Report Number
    16746934
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 29, 2023
    Report Date
    March 30, 2023
    Manufacturer
    SECA GMBH CO. KG
    Product Code
    FRI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT REPORTED BY PROGRAM MANAGER OF C5A, "BATTERIES FELL OUT OF SCALE AND PCA REPLACED THEM. THE MACHINE WOULD NOT POWER ON, SO SHE TOOK THE BATTERIES OUT TO MAKE SURE THEY WERE IN PROPERLY. WHEN SHE DID SO AND HIT THE POWER BUTTON, THE MACHINE BEGAN TO SMOKE AND SMELLED LIKE BURNING MATERIAL. CODE RED WAS ACTIVATED." SCALE WAS BROUGHT TO DIRECTOR OF BIOMED BY ENGINEERING SERVICE REP WHO RESPONDED TO THE CODE RED. ENGINEERING REP INDICATED HE SAW SMOKE COMING FROM THE SCALE UPON HIS ARRIVAL, AND HE INSTANTLY REMOVED THE BATTERIES. HE DID NOT NOTE THE TYPE OF BATTERY OTHER THAN VERIFYING THEY WERE STANDARD AA BATTERIES (WHICH THE SCALE TAKES). HE WAS UNABLE TO STATE WHETHER THE APPROPRIATE POLARITY WAS OBSERVED WHEN HE REMOVED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827088 SECA SCALE, STAND-ON, PATIENT FRI SECA GMBH CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown