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

Model Number	HEB0000-34
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Multiple Fractures (4519)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo received a notification regarding the event with a sara flex active lift.It was reported that a resident of the nursing home, who is suffering from severe osteoporosis, was being transported in a standing aid from the bed to the bathroom.Following the information received the resident was helped to stand up with the standing aid and in this moment broke her ankle.The resident was not able to stay up and sinks in the device.She could not hold the feet on the platform, but the safety belt used to keep the feet close to the footrest has been removed.This caused that the person rotated in the device.This contributed to a fracture of both femurs.It was reported that the resident is still in hospital.

• 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
• MDR Report Key: 13666419
• Report Number: 1419652-2022-00007
• Device Sequence Number: 12141553
• Product Code: FSA
• UDI-Device Identifier: 05056097354941
• UDI-Public: (01)05056097354941(11)200916
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2022
• Report Date (Section F): 03/04/2022

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?: No
• Operator of Device: Other
• Device Model Number: HEB0000-34
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2022
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2022
• 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; Life Threatening
• Patient Sex: Female
• Date Report Sent to FDA: 03/04/2022