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

Model Number	MAA2040M-LL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was informed about an incident involving the arjo passive clip sling (model number: maa2040m-ll, serial number: (b)(4)) and the ceiling lift from the tr-care company (non-arjo device).It was reported that while transferring the patient, the right shoulder sling clip became loose, resulting in the patient falling to the floor and hitting her head on the shower seat.As a result of this incident, the patient sustained a nosebleed and a hip fracture that required surgical intervention.
Additional Manufacturer Narrative
Arjo was informed about an incident involving the arjo passive clip sling (model number: maa2040m-ll, serial number: (b)(4)) and the ceiling lift from the tr-care company (non-arjo device).It was reported that while transferring the patient, the right shoulder sling clip became loose, resulting in the patient falling to the floor and hitting her head on the shower seat.As a result of this incident, the patient sustained a nosebleed and a hip fracture that required surgical intervention.After the event, the sling was evaluated by an arjo representative.The service technician informed that the sling was working properly and did not show any signs of wear.The technician did not evaluate the ceiling lift involved in the incident as he was unable to assess the device.The instructions for use (ifu) for the passive clip slings (document number: 04.Sc.00-int1_6) states that: ¿the passive clip slings should be used together with arjo lift devices in accordance with the allowed combinations specified in the instructions for use (ifu).¿ the document also warns: ¿to avoid injury, always follow the allowed combinations listed in this ifu.No other combinations are allowed.¿ non-arjo device ¿ ceiling lift from the tr-care company 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 ceiling lift and arjo passive clip sling were used as a system for a patient transfer when the resident fell out of the device and sustained a serious injury and from that perspective the system failed.As a medical device manufacturer, arjo is responsible to ensure that its medical device and its authorized accessories are safe and effective for use in accordance with the product¿s instructions for use manual.Arjo recommends the use of arjo branded slings to be utilized with arjo patient lifts in accordance with the devices¿ instructions for use manual.We decided to report this complaint to the competent authorities due to allegation that the clip detached during use resulting in a serious injury.

• 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: 14039639
• Report Number: 3012292104-2022-00004
• Device Sequence Number: 4698362
• Product Code: FSA
• UDI-Device Identifier: 05056097360126
• UDI-Public: (01)05056097360126(10)300321652057(11)210319
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MAA2040M-LL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 72 KG