MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S30 IQ; ELEVATOR

Model Number EU:SCALAMOBILS30IQ

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Injury (2348)

Event Date 11/23/2017

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.This report is for the patient adverse event.The attendant adverse event was filed separately.There is no evidence of a malfunction of the product.The stair geometry was complex requiring a trained and competent attendant using the scalamobil.The attendant in this case made a user error by not balancing the center of mass appropriately.Attendants are to receive documented training before using the device, the dealer was not able to provide a written training record for this attendant.

Event Description

A scalamobil has fallen down the stairs while in use with a patient.Both the patient and the attendant were involved and had a stay in the hospital due to the accident.

• Brand Name: SCALAMOBIL S30 IQ
• 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: 7447436
• MDR Text Key: 106069582
• Report Number: 3004730072-2018-00003
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/26/2018

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:SCALAMOBILS30IQ
• Device Catalogue Number: SCALAMOBILS30IQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2006
• 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
• Patient Age: 80 YR