MAUDE Adverse Event Report: ALBER GMBH E-MOTION M25

Model Number M25

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Vertigo (2134); Concussion (2192)

Event Type  Injury  

Event Description

Allegedly the patient was sitting in the wheelchair whilst being pushed manually up a ramp by the wife.The wife lost the grip and was not able to brake fast enough the wheelchair resulting that the wheelchair lifted on the front wheels tilted backwards on the ramp causing a hit/fall of the patient on the ground with the back of the head.Patient experienced by the fall/hit on the ground concussion, cramps in legs and short-therm spinning vertigo symptoms.The patient reported that the anti-tippers had come loose and the respective quick pins were bent by the event.

Manufacturer Narrative

This event occurred in germany.Alber gmbh is filing this report because the device is marketed and sold in the u.S.Alber performed an investigation.Conclusion out of the investigation is that it can be assumed that the anti-tippers were not correctly mounted on the day of the event.

• Brand Name: E-MOTION M25
• Type of Device: E-MOTION
• 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: 16474823
• MDR Text Key: 310593688
• Report Number: 3004730072-2023-00001
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192618
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M25
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• 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