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

Model Number	KTBB4BSA2WW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient transfer, two caregivers lift patient from the bed and the leg sling detached.The patient fell out of bed.No injury was sustained.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclsuion.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Arjo was informed about event involving arjo passive maxi twin lift and sling (model maa4160m-l, serial number b)(6)).The customer reported that patient was transferred from a bed with the assistance of 2 caregivers.When the patient was lifted, the sling leg clip detached.As a consequence of the event patient fell out of bed, no injury was sustained.After the event, the sling and lift were evaluated by an arjo representative.The device inspection revealed that no malfunction was found.Despite attempts to contact the customer and request additional information, arjo did not receive more information regarding the event circumstances.The maxi twin instruction for use contains graphical images showing how to attach the clips to the lift and contains a warning: -warning ¿to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process.¿ due to limited information provided by the customer, the exact root cause of the reported clip detachment failure is impossible to define.To sum up, the arjo floor lift and clip sling were used as a system during the patient transfer.The clip detached from the lift spreader bar and from that perspective system did not meet its performance specification.We decided to report this complaint to the competent authorities due to the allegation that the clip detached from the spreader bar during use.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14692387
• Report Number: 3007420694-2022-00093
• Device Sequence Number: 20527717
• Product Code: FSA
• UDI-Device Identifier: 05055982787154
• UDI-Public: (01)05055982787154(11)200806
• 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: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2022

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: KTBB4BSA2WW
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 05/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/12/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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