MAUDE Adverse Event Report: KI MOBILITY AXIOM DEEP LATERAL BACK; REPLACEMENT SOLID BACKREST

Model Number	AXIOM DL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is insufficient information to verify component failure or defect.It is unknown whether another group home member or staff actuated the release latches.We are in the process of trying to recover the equipment for evaluation.
Event or Problem Description
During transfer of the patient from the chair, they failed and the patient fell backwards into the chair.This resulted in the patient striking the backrest and the backrest disconnected allowing the patient to fall backwards and hit their head.They said they believe the backrest disconnected because it was unlatched, but they don't know by whom and when.
Additional Manufacturer Narrative
The device was discarded rather than returning for evaluating.There is insufficient information to verify component failure or defect.It is unknown whether another group home member or staff actuated the release latches.
Event or Problem Description
During transfer of the patient from the chair, the transfer failed and the patient fell backwards into the chair.This resulted in the patient striking the backrest and the backrest disconnected allowing the patient to fall backwards and hit their head.They said they believe the backrest disconnected because it was unlatched, but they don't know by whom and when.

• Brand Name: AXIOM DEEP LATERAL BACK
• Common Device Name: REPLACEMENT SOLID BACKREST
• Manufacturer (Section D): KI MOBILITY; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 5201 woodward drive; stevens point, WI 54481
• MDR Report Key: 19133218
• Report Number: 3005905321-2024-00002
• Device Sequence Number: 20539522
• Product Code: KNN
• UDI-Device Identifier: 00850013379170
• UDI-Public: (01)00850013379170
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AXIOM DL
• Device Catalogue Number: AXDL 2018
• Device Lot Number: 19823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown