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.

• 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
• MDR Report Key: 14039638
• Report Number: 1419652-2022-00011
• Device Sequence Number: 14627282
• 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: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2022
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Date Report Sent to FDA: 04/07/2022