MAUDE Adverse Event Report: KI MOBILITY, LLC CATALYST 4; MECHANICAL WHEELCHAIR

Model Number	CATALYST 4
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Therapist told dealer that user was reaching forward for something in dining room, and said that left caster bottom left eccentric nut worked itself out, it does not seem broken per dealer.Bolt was backed half way out and the washer and nut was missing when he received the chair.User was taken to hospital and diagnosed with subdural hematoma.(bump on head) returned last night to the facility.In the hospital notes per therapist, it stated neuro surgery was consulted and no pain in his back, no distracting injuries.Ct was neg for injury, he has full range of motion and the cervical collar was cleared.Ct of the head showed small subdural hematoma.

• Brand Name: CATALYST 4
• Common Device Name: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer (Section G): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: 5201 woodward drive; stevens point, WI 54481 ; 8009811540
• MDR Report Key: 16018249
• Report Number: 3005905321-2022-00005
• Device Sequence Number: 15123008
• Product Code: IOR
• UDI-Device Identifier: 00850013379019
• UDI-Public: 00850013379019
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CATALYST 4
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown