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

Model Number	KTBB4BSX2WW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was transfer with maxi twin passive floor lift and sling (maa4000m-xxl, serial number (b)(6)).During the transfer the sling left clip detached and patient fell out of the device.The caregivers were lifted one thigh of the patient when positioning above the bed at the time when the event occured.Head injury confirmed and hospitalization of the patient after the event.

• 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: 18834848
• Report Number: 1419652-2024-00025
• Device Sequence Number: 18006821
• Product Code: FSA
• UDI-Device Identifier: 05055982787154
• UDI-Public: (01)05055982787154(11)230424
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2024
• Report Date (Section F): 03/05/2024

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: KTBB4BSX2WW
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2024
• Date Report to Manufacturer: 03/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• 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: Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/05/2024