MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV SARA 3000; LIFT, PATIENT, NON-AC-POWERED

Model Number HEA0002

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon investigation conclusion.

Event Description

It was reported that while mobilizing in the bath using an active lift, the patient raised their arms , causing the patient to slip out of the sling and fall.As a consequence of the event the patient sustained a left anterior shoulder dislocation.The customer reported that the patient passed away 20 days after the event, however, the customer confirmed that the patient's death was not related to the event.

Manufacturer Narrative

Additionl information will be provided upon investigation conclusion.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration#3007420694) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#1419652).The patient was mobilized in the bath by using sara 3000 active floor lift.During the transfer, as the patient was being raised from the bath, she released her hands from the handle of the device and fell out of the lift.As a consequence of the event, the patient sustained a left anterior shoulder dislocation.The customer reported that the patient passed away 20 days after the event.The doctor from the facility confirmed that the patient's death was not related to the event.After the event, the device was evaluated by arjo.The visual inspection revealed that the support arm was bent.The functional test showed that the actuator was noisy.No malfunction was found which might have led to the patient fall.Sara 3000 is a mobile raising aid, intended to be used on a horizontal surface for raising to a standing position and short transfer of residents where the resident has been clinically assessed by cargivers to correspond to the following categories: sits in a wheelchair.Is able to partially bear weight on at least one leg.Has some trunk stability.Is dependent on the caregiver in most situations.Needs mobility-maintaining standing exercises.The instruction for use for sara 3000 device also contains warning: "warning: before attempting to raise a resident, a full clinical assessment of the resident¿s condition & suitability must be carried out by a qualified person on the individual resident to determine if it is advisable that he or she will be lifted using a sara 3000 standing and raising aid." also, the instruction for use contains information that before the transfer, the resident must hold on to the resident support grips with one or both hands.In the reported complaint it was confirmed that during raising the patient decided to let go of the device support handles (grips), what led to fall.To sum up, arjo active floor lift and active sling were used as a system for patient's transfer when the patient slipped out of the device.There were no abnormalities found within the lift or the sling that could have contributed to the event.The complaint was decided to be reportable due to the patient¿s fall and sustained serious injury.

• Brand Name: SARA 3000
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• Manufacturer (Section G): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16671921
• MDR Text Key: 312592237
• Report Number: 3007420694-2023-00070
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HEA0002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Sex: Female
• Patient Weight: 79 KG