MAUDE Adverse Event Report: ALBER GMBH E-MOTION M15

Model Number M15

Device Problem Mechanical Jam (2983)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

This incident occured in (b)(6) involving a product manufactured by (b)(4) in (b)(6).(b)(4) is filing this report because the device is marketed and sold in the u.S.(b)(4) analyzed the device and we make the justified assumption that the wheels/handrims have been damaged by external forces (repeatedly driven against obstacles or improper securing during transport).As a result mechanical parts were severely deformed causing a non valid continuos signal from the push rim (longer than one wheel rotation) which triggered an intended fault safety function of the device to interrupt the electrical support, which was considered as a block of the device by the end customer.

Event Description

The end user reported that the e-motion wheel suddenly blocked on a slight slope, causing the end user to fall out of the chair causing fracture of the lower legs with the need of a hospitalization and recovery in an orthopedic clinic.The end customer informed (b)(4) that he had noticed some time before the incident occured that the e-motion wheels reacted sporadically and that he had planned to send the product in for inspection/repair, which was not possible due to personal circumstances.

• Brand Name: E-MOTION M15
• Type of Device: E-MOTION M15
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 21; albstadt, baden-württemberg 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 21; albstadt, baden-württemberg, germany 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 21; albstadt, baden-württemberg, germany 72461 ; GM 72461
• MDR Report Key: 9086580
• MDR Text Key: 163382725
• Report Number: 3004730072-2019-00005
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K003449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/30/2019

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: M15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2008
• 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