FDA Adverse Event Malfunction Summary report: N

LIKORALL 200

MDR report key: 21383083 · Received February 14, 2025

Report

Report Number
8030916-2025-00030
Event Type
Malfunction
Date Received
February 14, 2025
Date of Event
January 22, 2025
Report Date
February 14, 2025
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FSA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

UPON INSPECTION THE HRC TECHNICIAN FOUND THE EMERGENCY STOP BUTTON WAS MISSING AND NEEDED TO BE REPLACED. LIKORALL OVERHEAD LIFT IS A STATIONARY LIFT MOUNTED IN A RAIL SYSTEM. THE RAIL SYSTEM CAN BE BUILT STRAIGHT, WITH OR WITHOUT CURVES, AS A TRAVERSE SYSTEM AND ALSO AS A ROOM-TO-ROOM SYSTEM. LIKORALL OVERHEAD LIFT IS INTENDED FOR USE IN LIFTING AND TRANSFERRING PATIENTS, FOR EXAMPLE, FROM BED TO A WHEELCHAIR, TO OR FROM THE FLOOR, FOR VISITS TO THE TOILET, FOR GAIT, STANDING AND BALANCE TRAINING, WHEN WEIGHING THE PATIENT AND WHEN LIFTING THE PATIENT WITH A STRETCHER. THE BAXTER TECHNICIAN REPLACED THE EMERGENCY STOP BUTTON TO RESOLVE THE REPORTED ISSUE. BASED ON TIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

Description of Event or Problem · 0

TECHNICAL SERVICE IDENTIFIED THAT LIKORALL 200 HAD AN ISSUE, EMERGENCY STOP BUTTON REPLACEMENT. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1415754 LIKORALL 200 LIFT PATIENT NON AC POWERED FSA BAXTER HEALTHCARE CORPORATION 3121001 NA

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown