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 evlauation did not revealed any device or sling malfunction.No signs of problem was found on the hoist that might contribute to device shaking.

Manufacturer Narrative

Additional information will be provided upon investgation conclusion.

Manufacturer Narrative

It was reported that a patient was transferred from a bed to a shower by using a maxi twin passive floor lift and bath sling with serial number (b)(6).The caregivers reported that in the middle of a transfer the lift started to ¿shake¿ and the patient fell out from the device through the middle section of the sling.As a consequence of the event, the patient sustained fracture of the collarbone and humerus bone.During the device inspection, there was no device malfunction which might lead to the reported device "shaking".Therefore, the customer allegation was not confirmed.Based on information provided despite the recommendation for the patient to use a size l sling, the caregivers chose a size xl during the event.Moreover, during the interview at the facility, the clinical nurse stated that the patient was prone to movement during the transfer due to her cognitive state.The described situation might be a factor of the device shaking that was noticed.According to the procedures provided in the instructions for the use of the maxi twin: ¿crossed leg attachment - if the resident is prone to kicking, the crossed leg attachment the clips/loops must be applied.This prohibits the leg clips/loops from detachment due to kicking and prevents the resident from possible injury." during the interview with the customer, it was confirmed how the sling was applied during the transfer.The customer stated that the sling leg clips were not crossed.To sum up, the patient's sudden movement might lead to device movement and as a consequence patient fall.To sum up, the arjo lift and arjo passive sling were used as a system for a patient transfer when the patient fell out of the device and sustained a serious injury, and from that perspective, the system failed.The complaint was decided to be reportable due to allegation that the sling clip detached during transfer.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18921469
• MDR Text Key: 337869874
• Report Number: 3007420694-2024-00077
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 74 KG