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

Model Number	MFA2100-L-L1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Arjo was informed about an event involving non arjo lift beka hopitec lift carlo and arjo sling loop.It was reported that during a patient transfer the patient fell out of the sling.No injury was reported.After the event the sling was evaluated by arjo representative.The sling inspection did not reveal any malfunction.The instructions for use (ifu) for the passive clip slings (document number: 04.Sc.00-int1_6) 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 ¿ beka hopitec lift carlo 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 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 beka hopitec lift carlo and arjo sling loop.It was reported that during a patient transfer the patient fell out of the sling.No injury was reported.After the event the sling was evaluated by arjo representative.The sling inspection did not reveal any malfunction.

• Brand Name: FLITES
• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17169104
• Report Number: 3012292104-2023-00004
• Device Sequence Number: 15242297
• Product Code: FSA
• UDI-Device Identifier: 05055982787994
• UDI-Public: (01)05055982787994(10)DIG1313566(11)210928
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Other
• Device Model Number: MFA2100-L-L1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/21/2023
• Date Device Manufactured: 09/28/2021
• 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: Other
• Patient Sex: Unknown