MAUDE Adverse Event Report: ALBER GMBH E-MOTION M15

Model Number M15

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Different descriptions of how the event occured were provided: allegedly the patient turned on e-motion in her home and drove the unit against the wall and hurt her shoulder.Allegedly when pushing the e-motion it felt aggressive and drove against a wall.Allegedly the patient used the device outside and tried to reach the ecs (control unit) when she hurt her shoulder.Patient had to stay a night at a hospital.

Manufacturer Narrative

This event occured in finland.Alber gmbh is filing this report because the device was marketed and sold in the u.S.Alber performed an investigation of the returned involved device.No failures were detected on the test bench.The function of the e-motion wheels was inconspicuous and as expected.No abnormalities were found on the entire device that could lead to a malfunction of the e-motion.

• Brand Name: E-MOTION M15
• Type of Device: E-MOTION M15
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 14; albstadt, baden-württemberg, germany 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 14; albstadt, baden-württemberg, germany 72461 ; GM 72461
• MDR Report Key: 14998145
• MDR Text Key: 295770020
• Report Number: 3004730072-2022-00005
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K003449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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: 07/08/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• 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