MalfunctionING
SCALAMOBIL S35
Received Jun 25, 2021
Report 3004730072-2021-00003 · MDR key 12065277
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURED IN (B)(6). ALBER (B)(4) IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. ALBER (B)(4) WILL START THE PHYSICAL EVALUATION OF THE DEVICE (DEVICE RETURNED TO ALBER (B)(4) 23 JUNE 2021).
Description of Event or Problem
IT WAS REPORTED, THAT THE WHEEL MECHANISM HAS BECOME OUT OF SYNC DURING USE ON A STAIRS CLIMB. THE END-USER/PATIENT DID NOT FALL AND WAS NOT INJURED. THE DEVICE HAS LESS THAN A MONTH OF USE.
Remedial action
- Inspection