BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCALAMOBIL S36

    MDR report key: 12056657 · Received June 24, 2021

    Report

    Report Number
    3004730072-2021-00002
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 19, 2021
    Manufacturer
    ALBER GMBH
    Product Code
    ING
    PMA / PMN Number
    K920105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED STAIRCLIMBER WAS EXAMINED IN DETAIL. FROM A TECHNICAL POINT OF VIEW, NO DEFECTS COULD BE FOUND WHICH COULD HAVE CAUSED THE ACCIDENT DESCRIBED. ACCORDING TO THE INSTRUCTIONS FOR USE (PAGE 31), INSTRUCTION ON THE DEVICE SHOULD HAVE BEEN GIVEN BY A AUTHORIZED DEALER OR AGENT OF ALBER: "THE SCALAMOBIL MUST ONLY BE OPERATED BY PERSONS WHO HAVE PARTICIPATED IN THE INSTRUCTION SESSION PROVIDED BY THE AUTHORISED DEALER OR AN AGENT OF ALBER GMBH. DURING THE INSTRUCTION SESSION PROVIDED BY YOUR AUTHORISED DEALER OR AN AGENT OF ALBER GMBH, ENSURE THAT YOU ARE PROPERLY INFORMED OF ALL THE FUNCTIONS OF THE SCALAMOBIL AND ITS OPERATION AS A STAIR CLIMBER. IN ADDITION, TEST THE DEVICE BY CLIMBING A STAIRCASE WITH AN EMPTY WHEELCHAIR TO FAMILIARISE YOURSELF WITH THE STAIR CLIMBER¿S OPERATING BEHAVIOUR.¿ WE MAKE THE EDUCATED GUESS THAT THE INCIDENT DESCRIBED WAS CAUSED BY AN OPERATING ERROR.

    Description of Event or Problem · 0

    THE OPERATOR (NURSE ASSISTANT/CAREGIVER) WANTED TO TRANSFER THE PATIENT DOWN A STAIRCASE WITH 4 STEPS ON (B)(6) 2021. AFTER THE SECOND STEP, THE STAIRCLIMBER COULD NO LONGER BE OPERATED, THE SEAT AND THE BACKREST FLEW OUT AND THE OPERATOR AND THE PATIENT FELL DOWN THE STAIRS. THE PATIENT SUFFERED LACERATIONS, BRUISES, CONTUSIONS AND ABRASIONS ON THE LEGS. THE OPERATOR SUFFERED BRUISES TO THE BODY AND NOSE. BOTH THE PATIENT AND THE OPERATOR WERE TREATED AT THE EMERGENCY ROOM OF THE HOSPITAL. THE OPERATOR IS EMPLOYED AS A NURSING ASSISTANT/CAREGIVER BY THE DAUGHTER. ONE OF THE PATIENT'S DAUGHTERS INSTRUCTED THE OPERATOR IN THE HANDLING AND OPERATION OF THE SCALAMOBIL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). ALBER GMBH IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. ALBER GMBH WILL START THE PHYSICAL EVALUATION OF THE DEVICE (DEVICE RETURNED TO ALBER GMBH 22 JUNE 2021).

    Description of Event or Problem · 1

    THE OPERATOR (NURSE ASSISTANT/CAREGIVER) WANTED TO TRANSFER THE PATIENT DOWN A STAIRCASE WITH 4 STEPS ON (B)(6) 2021. AFTER THE SECOND STEP, THE STAIRCLIMBER COULD NO LONGER BE OPERATED, THE SEAT AND THE BACKREST FLEW OUT AND THE OPERATOR AND THE PATIENT FELL DOWN THE STAIRS. THE PATIENT SUFFERED LACERATIONS, BRUISES, CONTUSIONS AND ABRASIONS ON THE LEGS. THE OPERATOR SUFFERED BRUISES TO THE BODY AND NOSE. BOTH THE PATIENT AND THE OPERATOR WERE TREATED AT THE EMERGENCY ROOM OF THE HOSPITAL. THE OPERATOR IS EMPLOYED AS A NURSING ASSISTANT/CAREGIVER BY THE DAUGHTER. ONE OF THE PATIENT'S DAUGHTERS INSTRUCTED THE OPERATOR IN THE HANDLING AND OPERATION OF THE SCALAMOBIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959343 SCALAMOBIL S36 SCALAMOBIL ING ALBER GMBH S36

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization