MAUDE Adverse Event Report: KI MOBILITY FOCUS; FOCUS CRE

Model Number	FOCUS CRE
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The component returned had significant wear on the wheel lock from what appeared to be severe rubbing on the tire.The metal face of the wheel lock interfacing with the tire was significantly worn away.Wheel locks are not to be used as brakes to slow or stop the wheelchair.See user manual dcn0255 rev 6.No proof of required maintenance was found.
Event or Problem Description
It was stated the left wheel lock would not hold and engage.The user was going to transfer from bed to the chair and when he went to engage wheel lock.The wheel lock slipped, the user fell forward hitting his head on a dresser causing him to cut his head and required stitches.

• Brand Name: FOCUS
• Common Device Name: FOCUS CRE
• Manufacturer (Section D): KI MOBILITY; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 520 woodward drive; stevens point, WI 54481
• MDR Report Key: 21618031
• Report Number: 3005905321-2025-00002
• Device Sequence Number: 17826080
• Product Code: IOR
• UDI-Device Identifier: 00850013379118
• UDI-Public: (01)00850013379118(11)20240409
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: FOCUS CRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown