MAUDE Adverse Event Report: ALBER GMBH E-MOTION M15

Model Number M15

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Alber gmbh is filing this report as an alber product is allegedly involved in the event and the patient got injured.Alber is trying to obtain more information about the event.

Event Description

Allegedly the event occured on (b)(6) 2022 whilst driving down a ramp installed to the patient´s van.Half way of the ramp the right side of the wheelchair collapsed causing that the patient fall out of the wheelchair on the ground.The patient got a hurt and needed emergency assistance.

• 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: 14905756
• MDR Text Key: 295227075
• Report Number: 3004730072-2022-00004
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M15
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Date Device Manufactured: 11/04/2014
• 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
• Patient Sex: Male