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

Model Number EU:1520415

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

The incident occurred in (b)(6); invacare is filing this report because the device is also marketed and sold in the u.S.The scalamobil has not been returned for an evaluation.An investigation was performed by using the same model scalamobil and wheelchair in a simulation of the setting where the accident occurred.The allegation of the scalamobil rolling away could not be duplicated when on even ground.No alleged malfunction/deficiency was found with the device.Based on the information provided and the investigation, it was determined the most probable cause of the event was the system was not parked on even ground.The manual states: you should park the scalamobil with manual wheelchair on even ground with aligned wheels.If more information is received, follow up record will be filed.

Event Description

The operator of the scalamobil transferred the patient (sitting in a wheelchair) down a staircase with 8 steps.There were no issues with the stair-climbing process; the scalamobil ran without problems.The operator left the patient alone (sitting in the wheelchair and still connected to the scalamobil) in the street area near the curb; the patient rolled away and fell over the curb onto her face.She suffered a broken cheekbone and had to be admitted to hospital.

• Brand Name: SCALAMOBIL S35
• Type of Device: ELEVATOR, WHEELCHAIR, PORTABLE
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen; stein 21; albstadt 72461 ; GM 72461
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8214360
• MDR Text Key: 131983162
• Report Number: 3004730072-2019-00001
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2018

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: Lay User/Patient
• Device Model Number: EU:1520415
• Device Catalogue Number: 1520415
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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): Hospitalization