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

Model Number	KTBB4BSU2WW
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.The results will be provided upon conclusions of the investigation.
Event or Problem Description
Following the information reported, the maxi move passive floor lift tipped over.A certified nursing assistant (cna) sustained the left shoulder strain while stopping the lift from hurting the resident.X-rays were taken and no fracture was noticed.No magnetic resonance imaging (mri) was needed.Cna was released from the hospital.Although it was claimed by the customer that the floor lift legs would not open, such issue was not found during the device inspection.
Additional Manufacturer Narrative
Following the information reported, the maxi twin passive floor lift tipped over.A certified nursing assistant (cna) sustained the left shoulder strain while stopping the lift from hurting the resident.X-rays were taken and no fracture was noticed.No magnetic resonance imaging (mri) was needed.Cna was released from the hospital.Although the customer claimed that the chassis' left leg would not close, such an issue was not recreated during device inspection and functional testing.No device malfunction could contribute to the device tipping found.According to the device functionality, the position of the chassis legs can be changed.During opening the chassis, the right leg is opened first and when reaches maximum position then the right leg is opened.During inspection, the proper opening and closing of legs was confirmed.The instructions for use (ifu, 04.Kt.00_18) dedicated to the maxi twin passive floor lift states: "to avoid the possibility of injury always make sure that the maxi twin lift is kept with the chassis legs in parallel (closed) position during transfer." following the information gathered, the facility staff used the lift with one leg open.This could cause the instability of the device and the device tipping.Arjo device failed to meet its performance specification since the floor lift tipped over.The device was used for a patient transfer.The complaint decided to be reportable due allegation of lift tipping.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18370603
• Report Number: 3007420694-2023-00305
• Device Sequence Number: 20760894
• Product Code: FSA
• UDI-Device Identifier: 05055982793360
• UDI-Public: (01)05055982793360(11)200113
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: Other
• Device Model Number: KTBB4BSU2WW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown