MAUDE Adverse Event Report: ALBER GMBH ALBER SCALAMOBIL S35; ELEVATOR

Model Number EU:1097

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u.S.An investigation of the event and inspection of the device were performed.The device was received in as is condition.Inspection revealed external damage consistent with a crash caused by forward tilt such as the device falling down the staircase.The examination showed no signs of any technical defects.The investigation confirmed that the damage was caused because of the fall, the were no signs of defect/malfunction prior to the event.After replacing the external parts damaged by the fall, it was confirmed the scalamobil functioned as it should with no issues or defects.The dealer stated the cause of the event was user error.The attendant did not maintain the center of gravity during use and let go of the scalamobil.There are multiple warnings in the owner's manual including: "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/down the stairs." the function checks section of the manual includes: "for safety reasons, always test the brakes before climbing a staircase.This check must be performed without attached wheelchair and while the scalamobil is switched off.If one or both brakes fail to work properly, do not operate the scalamobil under any circumstances.".

Event Description

The patient was being taken down the stairs in the scalamobil.The scalamobil was connected to a wheelchair with seat shell.The attendant alleges that the brake was not functioning.The patient and the attendant fell down the stairs.

• Brand Name: ALBER SCALAMOBIL S35
• Type of Device: ELEVATOR
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21; albstadt, germany 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen; stein 21; albstadt, germany 72461 ; GM 72461
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 7487684
• MDR Text Key: 107379079
• Report Number: 3004730072-2018-00005
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2018

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: Other Caregivers
• Device Model Number: EU:1097
• Device Catalogue Number: 1097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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): Required Intervention