MAUDE Adverse Event Report: ALBER GMBH E-MOTION M25

Model Number M25

Device Problem Misassembled During Installation (4049)

Patient Problem Bruise/Contusion (1754)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

This event occured in (b)(6).Alber gmbh is filing this report because the device is marketed and sold in the u.S.On 02 sep 2021, during an on-site visit at the end customer by the alber district manager, the involved e-motion m25 was inspected.It was found that: the bracket on the left side of the wheelchair has come loose and therefore the tilt support height on the left side has changed, currently to 13 cm.On the left anti-tilt support a counter nut was not mounted as described in the mounting instruction.The height of the anti-tilt support on the right side is 8,5 cm, the bracket has not come loose on the right side, therefore this is an indication that the height of the anti-tippers was incorrectly set during installation.The anti-tilt support height must be max.30mm according to the mounting instruction.The actual height of both anti-tilt support is above the permissible value (30mm).We assume that the max.Permissible anti-tilt support height of both anti-tilt supports was not given before the day of the accident.The mounting of the bracket as well as the adjustment of the anti-tilt support was carried out by the responsible medical supply store.As a result of the fact that the max.Permissible anti-tilt support height was not observed, the tipping angle of the anti-tippers changes to a negative effect.The maximum tipping angle of the wheelchair to the back and the forces acting on the anti-tilt support as well to the bracket is increased if the anti-tippers are set too high.Due to the fact that the maximum tipping angle to the back was not given on the day of the accident, the anti-tippers could not prevent a complete tipping to the back and the bracket on the left side of the wheelchair came loose.The incorrect mounting of the bracket and the incorrect adjustment of the anti-tilt support led to the accident.The mounting instructions for the anti-tilt support on page 2 explicitly references to the max.Permissible anti-tilt support height.The responsible medical supply store has already rectified the holder and the anti-tilt support in accordance with the manufacturer's instructions.The alber district manager has checked the rectifications carried out by the responsible medical supply store before redelivery to the customer.

Event Description

End customer informed by phone that on (b)(6) 2021 wanted to drive the driveway with her wheelchair and attached e-motion m25 uphill.While driving, the wheelchair tipped backwards and the anti-tippers failed, causing the end customer to fall backwards onto the back of her head.The end customer had to be treated by an emergency physician as well as in the hospital.The end customer suffered bruises.

• Brand Name: E-MOTION M25
• Type of Device: E-MOTION M25
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• MDR Report Key: 12458846
• MDR Text Key: 270985258
• Report Number: 3004730072-2021-00004
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K192618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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