MAUDE Adverse Event Report: SCALAMOBIL S36

Model Number S36

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 09/18/2021

Event Type  Injury  

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 once it arrives at our premises.

Event Description

The event occurred on (b)(6) 2021.The device was operated by the patient's partner.The device was used in single step mode speed 5 or 6.The accident happened while climbing upstairs between stair step 4 and 5 of eight steps.The patient fell downstairs forward 4 steps.The patient suffered various bruises on face, abrasions and a tooth broke off due to the fall.The emergency doctor admitted the patient to the hospital from where was released on (b)(6) 2021.

Manufacturer Narrative

Alber performed an inspection of the affected unit.A visual inspection and test drives on staircase were performed.The visual inspection did not reveal any signs of wear or breaks on the chains, brakes or drive wheels.The brakes have no damage and the thickness of the brake linings is sufficient.Several test drives (climbing upstairs and downstairs) were performed to check the function.No failures were detected during the climbing process (upstairs and downstairs).The function of the stairclimber was inconspicuous and as expected.The entire drive unit did not show any abnormalities that could have caused a malfunction of the stairclimber.We assume that the operator inadvertently failed to move the stairclimber wheels fully backwards to the step while climbing the stairs (between steps 4 and 5) so that the wheels were not touching the edge of the step (step 5).During the subsequent attempt to climb the next step, the wheels could not touch the next step (step 5), which led to a loss of control/balance of the stairclimber and consequent fall.The steps for climbing upstairs are described in the instructions for use on page 19: tilt the scalamobil towards you until it is at an optimum angle to the stairs and the stair climber with the passenger is well balanced.Maintain this angle during the entire climb up the stairs.Move the scalamobil backwards towards the stairs until the wheels of the scalamobil touch the first step.Move the scalamobil gently and avoid jerking.To climb up one step, actuate the driving switch [2] (see chapter 2.4.5) while pulling the scalamobil slightly towards the operator.Do not release the driving switch [2] while the scalamobil is climbing the step.When the scalamobil has reached the outer edge of the climbed step, release the driving switch [2] and move the scalamobil carefully to the next step.Avoid any jerking movements.Actuate the driving switch [2] again to climb the next step.Repeat the above steps until you reach the top of the stairs.

Event Description

The event occurred on (b)(6) 2021.The device was operated by the patient's partner.The device was used in single step mode speed 5 or 6.The accident happened while climbing upstairs between stair step 4 and 5 of eight steps.The patient fell downstairs forward 4 steps.The patient suffered various bruises on face, abrasions and a tooth broke off due to the fall.The emergency doctor admitted the patient to the hospital from where was released on (b)(6) 2021.

• Brand Name: SCALAMOBIL S36
• Type of Device: SCALAMOBIL
• MDR Report Key: 12531378
• MDR Text Key: 273293351
• Report Number: 3004730072-2021-00005
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: S36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization