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

Model Number EU:1520415

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

This incident occurred in (b)(6) involving a product manufactured by alber (b)(4) in (b)(4).Invacare is filing this report because the device is also marketed and sold in the u.S.The patient's husband stated that the device did not malfunction.He related neither the wheelchair that was attached to the scalamobil nor the scalamobil fell down the stairs during the accident.The wheelchair remained attached to the scalamobil.The patient was not wearing a harness system which is offered as an optional accessory.The husband has given permission for the scalamobile to be evaluated, as of the date of this report the scalamobil has not been returned.The date of the original event is not known.If more information is received, a follow-up record will be filed.

Event Description

Alber (b)(4) received a letter from the patient¿s husband on (b)(6) 2019.He relates the patient was sitting in a pyro start wheelchair which was attached on the scalamobil.He was using the device to transport her down a wide staircase at a restaurant.He came to the side of the wall and the device stopped.His wife came out of the chair and fell down five steps landing on a stone floor.She was unconscious and was taken to a clinic in (b)(6).On (b)(6) 2019 the husband reported the patient had remained in a coma until (b)(6) when she passed away.

• 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: 8503904
• MDR Text Key: 141598975
• Report Number: 3004730072-2019-00002
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EU:1520415
• Device Catalogue Number: 1520415
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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): Death; Hospitalization; Life Threatening