MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MAXI TWIN; LIFT, PATIENT, NON-AC-POWERED

Model Number	KTBB4BSU2WW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	11/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during resident transfer the left leg sling clip detached.As a consequence of the event the resident fell out from the device.The resident sustained fracture to the skull and brain bleed,.

• Brand Name: MAXI TWIN
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 20809491
• Report Number: 1419652-2024-00069
• Device Sequence Number: 13075052
• Product Code: FSA
• UDI-Device Identifier: 05055982793360
• UDI-Public: (01)05055982793360(11)200219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2024
• Report Date (Section F): 11/29/2024

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
• Operator of Device: Other
• Device Model Number: KTBB4BSU2WW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2024
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2024
• 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: Congenital Anomaly; Required Intervention; Other; Hospitalization; Disability
• Patient Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/29/2024