MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA FLEX; LIFT, PATIENT, NON-AC-POWERED

Model Number	HEB1000-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
The patient was assessed to transfer using the sara flex.She had been successfully transferring with the sara flex.On saturday (b)(6) 2024 the patient was no longer able to support herself as well causing the sling to ride up under her arms.The transfer from the toilet was completed.The patient complained of sore upper arms.Later she was transferred to the hospital and was demonstrated that she had vascular injury of the upper arm.The patient sustained chest wall hematoma that required hospitalization.
Additional Manufacturer Narrative
Additional information will be provided upon invvestigation conclsuion.
Additional Manufacturer Narrative
It was reported that a patient was assessed by caregiver to transfer using the sara flex active floor lift.The transfer was conducted without any problem with the sara flex.On saturday 20-apr-2024 the patient was no longer able to support herself which caused the sling to ride up under her arms.The transfer from the toilet was completed.The patient complained of sore upper arms and was transferred to the hospital.The sara flex instruction for use contains information that: "before use the caregiver should always consider the patients/residents medical condition, physical and mental capabilities." in addition the patient/resident must be able to bear weight on at least one leg and have some trunk stability be able to sit on the edge of the bed.To sum up, the patient was no longer able to support herself.Based on the information provided in the complaint, the patient had pre-existing diseases and medical conditions that could have caused the patient to become weak during the transfer.The patient condition might have influence on the reported injuries.To sum up, the arjo active floor lift was used.No device malfunction was reported.The complaint was decided to be reportable due to sustained serious injury by the patent after the transfer.

• Brand Name: SARA FLEX
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 19391890
• Report Number: 9681684-2024-00040
• Device Sequence Number: 12705687
• Product Code: FSA
• UDI-Device Identifier: 05056097354958
• UDI-Public: (01)05056097354958(11)210824
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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?: No
• Device Model Number: HEB1000-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/21/2024; 07/01/2024
• Date Device Manufactured: 08/24/2021
• 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 Sex: Unknown