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

Model Number NTB2000

Device Problem Use of Device Problem (1670)

Patient Problem Bruise/Contusion (1754)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

A company representative was informed about an incident involving an active lift.The reported incident occurred when the patient , was seated on the toilet with the lift positioned in front of her.Ms attempted to stand up using the lift, when the lift unexpectedly moved, causing patient to fell.The patient was caught by caregivers preventing her from landing on the ground.As a consequence of the event the patient sustained bruises on the arms.

Manufacturer Narrative

The customer reported that the patient was seated on the toilet, with the sara stedy active lift positioned in front of them.The patient attempted to stand using the sara stedy lift (the castors' brakes were engaged), the lift moved away, resulting in the patient's collapse through their legs.The patient was caught by the caregiver and did not land on the ground.As a result of the event, the patient sustained a few bruises on the arms.After the event the device was inspected by an arjo representative, the lift functional test showed that the brake function does not always engage to the full brake position.The castor brakes were replaced by the technician.The device was manufactured in 2011 and has been used for approximately 13 years.The sara stedy device instruction for use contains information that: "the expected operational life of your arjohuntleigh lift is ten (10) years from the date of manufacture." also, the preventive maintenance section in instruction for use indicated that before every use customers should check the rear castor brake function.The reported event was a sequence of unfortunate events, the reported castor brake malfunction by itself does not lead to patient fall.Looking at the incident scenario it has been established that a floor lift was used for patient handling at the time of the event.The brake malfunction was found, and from that perspective the device did not meet its specification.The complaint was decided to be reportable due to the allegation that the patient fell during transfer.

• Brand Name: SARA STEDY
• Type of Device: 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: 18638538
• MDR Text Key: 334506261
• Report Number: 9681684-2024-00008
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NTB2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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): Other
• Patient Age: 95 YR
• Patient Sex: Female
• Patient Weight: 64 KG