MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC SLINGS, CLIP; LIFT, PATIENT, NON-AC-POWERED

Model Number	MLA2000-M-L1
Medical Device Problem Codes	Use of Device Problem (1670); Unclear Information (4052)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Waiting for the additional information regarding the event from customer.
Event or Problem Description
A resident was being transferred from chair to bed.The resident was raised from the seat of the chair once the sling was positioned.The patient was lifted when the chair was removed the resident fell through the sling to the floor.Unfortunately, only the staff member controlling the hoist saw the fall occur, as the second staff member had her back turned as she relocated the chair.As consequence of the event the resident sustained bruising and a small head laceration.
Additional Manufacturer Narrative
The instructions for use (ifu) for the passive loop slings (document number: 04.Sl.00-int1_8) states that: ¿the passive loop slings are especially designed for ceiling lifts, floor lifts and accessories made by arjo.¿ the document also warns: ¿to avoid injury, always follow the allowed combinations listed in this ifu.No other combinations are allowed.¿ non-arjo device ¿ lift kcare healthcare involved in the incident is not listed in the sling instruction for use under combinations of devices allowed to be used with the arjo slings.To sum up, the non-arjo lift and arjo passive loop 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 patient slip out of the sling.
Event or Problem Description
Arjo was informed about an event involving non-arjo lift kcare healthcare model number: kh404f and serial number.: (b)(6)) and arjo sling clip.Following the information provided a patient was transferred from a chair to a bed.During raising the lift when the caregiver removed the chair, the patient fell through the sling on the floor (distance of approximately 80cm).As a consequence of the event, the patient sustained bruising and a small head laceration.The customer did not report any malfunctions of the lift or sling.
Additional Manufacturer Narrative
Waiting for additional information from the customer to conduct the investigation.

• Brand Name: SLINGS, CLIP
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer (Section G): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16822199
• Report Number: 9681684-2023-00026
• Device Sequence Number: 20545585
• Product Code: FSA
• UDI-Device Identifier: 05056341602385
• UDI-Public: (01)05056341602385(10)300820759(11)200828
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2023

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
• Device Model Number: MLA2000-M-L1
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/25/2023; 06/23/2023
• Date Device Manufactured: 08/28/2020
• 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