SCALAMOBIL S35
Received Feb 6, 2020 · Event occurred Dec 24, 2019
Report 3004730072-2020-00001 · MDR key 9675746
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Contusion
- Fall
- Contusion
- Fall
Narrative
Additional Manufacturer Narrative
THE INCIDENT OCCURRED IN GERMANY, ALBER IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. THE SCALAMOBIL HAS BEEN RETURNED FOR AN EVALUATION. AN INVESTIGATION WAS PERFORMED. THE BRAKE WHEEL IS NOT BROKEN BUT DEFORMED. THE VISIBLE DAMAGES (DEFORMATION OF THE BRAKE WHEEL) TO THE STAIRCLIMBER WERE CAUSED BY TIPPING TO THE SIDE. DESPITE OF THE VISIBLE DAMAGES (DEFORMATION OF THE BRAKE WHEEL) NO ALLEGED MALFUNCTION/DEFICIENCY WAS FOUND WITH THE DEVICE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS AN OPERATING ERROR.
Description of Event or Problem
DESCRIPTION RECEIVED VIA REPAIR ACCOMPANYING LETTER (09 JANUARY 2020) : ERROR OF BRAKE WHEEL. RIGHT IS LOOSE PERSON FELL AND LEFT BRAKE WHEEL IS BROKEN. UPDATE 28 JANUARY 2020 PHONE CALL BETWEEN OPERATOR AND ALBER GMBH: OPERATOR (HUSBAND OF THE PATIENT) INFORMED THAT ON (B)(6) 2019 THE STAIRCLIMBER TIPPED SIDEWAYS AWAY DURING A STAIR DESCENT AT THE HOME OF THE DAUGHTER. THE OPERATOR WAS ABLE TO PREVENT THE STAIRCLIMBER INCLUDING WHEELCHAIR AND PATIENT FROM FALLING DOWN THE STAIRCAISE (2-3 STEPS). THE PATIENT WAS STRAPPED IN HER WHEELCHAIR DURING THE DESCENT. THE PATIENT SUFFERED A CONTUSION ON ONE FINGER. NO MEDICAL INTERVENTION OR HOSPITALIZATION.
Remedial action
- Inspection