MAUDE Adverse Event Report: LIKO AB LIKORALL¿ OVERHEAD LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	3122501NA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During testing of the baxter likorall 250 es overhead patient lifts in february 2022, the biomedical engineering (bme) staff attached weight and engaged the emergency stop (e-stop).They observed the central suspension point (csp) drifting, which exceeded 50 millimeters (mm).This is violating iso-10535 4.6.1.3, which states "when loaded with the maximum load, the csp or the point of the hoist/body-support unit that moves over the largest distance shall have a vertical stopping distance of not more than 50 mm." bme worked with baxter, and baxter stated the lifts are compliant with iso-10535, 4.2.5.17, which states electrically operated hoists shall be provided with an emergency stopping device for fulfilling the requirements in iec 60601-1:2005+amd1: 2012+ amd2: 2020, 9.2.4¿ and 4.7.1.1 ¿the rate of lifting or lowering the central suspension point (csp) (reference point on bathtub hoists) shall not exceed 0.15 m/s when loaded." they provided an additional document where they state "as a result of activating the emergency stop, the self-breaking of the electrical motor will shut off which may allow the motor to drift when heavy load is applied.If the emergency stop button is activated during a lift situation and in case of a downward movement, caused by gravity, the patient will be lowered slowly." drift was observed in february 2023 and february 2024.Upon receiving the letter from baxter, the staff realized the behavior of the lifts can be characterized as inconsistent, and there's an element of unknown with how the lift will behave once the electricity is severed from the motor.This increased the concerns to patient and staff safety while using the lifts, and the bme department in collaboration with safe patient handling & mobility and patient safety decided to lockout the lifts to reduce the likelihood of an adverse event.

• Brand Name: LIKORALL¿ OVERHEAD LIFT
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; one baxter parkway; deerfield IL 60015
• MDR Report Key: 20597980
• Report Number: 20597980
• Device Sequence Number: 12962856
• Product Code: FSA
• UDI-Device Identifier: 00887761979499
• UDI-Public: (01)00887761979499
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/02/2024
• Report Date (Section F): 07/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 3122501NA
• Device Catalogue Number: 3122501NA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 07/31/2024