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

Model Number KTBB4BSX2AU

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/22/2024

Event Type  Injury  

Event Description

It was reported that patient was transfer from a bed to a shower commode by assistance of two caregivers.The carers began moving towards the chair to the right of the bed.During the transfer the hoist began to ¿shake¿ and the patient fell through the middle section of the sling.As a consequence of the event the patient sustained a fractured clavicle and humerus, the device evaluation did not revealed any device or sling malfunction.No signs of problem was found on the hoist that might contribute to device shaking.

• Brand Name: MAXI TWIN
• Type of Device: 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: 18921468
• MDR Text Key: 337870454
• Report Number: 1419652-2024-00026
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KTBB4BSX2AU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2024
• Distributor Facility Aware Date: 02/22/2024
• Device Age: 10 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 74 KG