MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S35; ELEVATOR,WHEELCHAIR,PROTABEL

Model Number S35

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

Patient Problems Contusion (1787); Fall (1848)

Event Date 12/24/2019

Event Type  Injury  

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.

Event Description

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.

• Brand Name: SCALAMOBIL S35
• Type of Device: ELEVATOR,WHEELCHAIR,PROTABEL
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 21; albstadt 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 21; albstadt 72461 ; GM 72461
• MDR Report Key: 9675746
• MDR Text Key: 177991647
• Report Number: 3004730072-2020-00001
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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): Other