MAUDE Adverse Event Report: SARA STEDY; LIFT, PATIENT, NON-AC-POWERED

Model Number NTB2000

Device Problems Device Slipped (1584); Unclear Information (4052)

Patient Problems Death (1802); Bone Fracture(s) (1870)

Event Type  Death  

Manufacturer Narrative

Collecting information is ongoing.Additional information will be provided upon investigation conclusion.

Event Description

It was reported, that patient was using sara stedy and fell out.As a consequence of the event sustained broken hip.Customer provided information that patient passed away.No other information was provided.There are no further details at this time.

Manufacturer Narrative

On 02 sep 2020 arjo account manager received a product inquiry raised by the customer.It was reported that the patient fall whilst using a sara stedy (active floor lift) in a shower.The initial allegation provided by the customer did not contain a detailed address of the customer site, serial number and there was no indication of an injury.On 28 sep 2020, an arjo service team leader (engineer) attended the site for unrelated reason and became aware that this patient sustained a broken hip and passed away.Following additional information gathered to the reported event, arjo has learnt that the fall occurred on (b)(6) 2020 and patient passed away on (b)(6) 2020.A nurse stated that she transferred the patient to the bathroom and to the shower.The patient was lowering herself on the shower seat when the lift slipped with the locked brakes.The nurse tried to support the patient to the floor.The patient sustained the right hip pain.Further examination revealed a fractured neck of femur.The lift was evaluated by an arjo service technician.A visual inspection showed small scratches on top of chassis legs.The lift was functional tested and no failure was detected.The arjo service technician was able to inspect the bathroom where the event happened.It was observed that the floor was uneven and when positioning the claimed device in or around the area of the shower seat, it was possible that 3 out of 4 castors were in contact with the floor.In summary, the sara stedy lift was used with the patient when the event occurred.During the lift evaluation, no device malfunction was detected.The complaint was decided to be reportable due to the allegation that the patient fell out of the device and the information that the patient passed away.

• Brand Name: SARA STEDY
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• MDR Report Key: 10619037
• MDR Text Key: 209553133
• Report Number: 9681684-2020-00064
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NTB2000
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death