MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 242 ES R2R; LIFT PATIENT NON AC POWERED

Model Number	P3122007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account has decided that they no longer need this over head lift.The customer reported that an out side contractor has been scheduled to remove the lift from service.Based on this information, no further actions are required at this time.Although there was no patient involvement reported and the event was caused by incorrect use of the device, if the motor was to drop from the ceiling during a patient transfer it could lead to a serous injury or death.Therefore baxter is reporting this event.
Event or Problem Description
A company representative - service personnel contacted technical service to report that the likorall 242 es r2r overhead lift fell off of the rail onto the floor, it was additionally reported that the lift had a turn table on it going into two different bathrooms and the account took it upon themselves to take down the railing going into one of the bath rooms not realizing that there was no way to stop the lift from falling off onto the floor.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKORALL 242 ES R2R
• Common Device Name: LIFT PATIENT NON AC POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20734550
• Report Number: 8030916-2024-00103
• Device Sequence Number: 8499694
• Product Code: FSA
• UDI-Device Identifier: 00887761979758
• UDI-Public: (01)00887761979758
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: P3122007
• Device Catalogue Number: P3122007
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown