MAUDE Adverse Event Report: LIKO AB LIKORALL 200; LIFT, PATIENT, NON-AC-POWERED

Model Number	3121001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged the lift¿s emergency stop was not engaging.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under hillrom complaint ref # (b)(4).
Additional Manufacturer Narrative
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 technical customer support specialist provided the account with the appropriate part number to resolve.Based on this information, no additional actions are necessary at this time.The periodic inspection manual for overhead lists (3en191001 rev 2) states the following caution: 5 emergency stop: check that the emergency stop cord is secured properly and has no damage.Activate the emergency stop button.Verify that holds and locks in the activated position.Although there was no associated injury reported with this event, if the emergency stop button were to stop functioning during patient transfer it could lead to a serious injury or death, therefore hillrom/baxter is reporting this malfunction.

• Brand Name: LIKORALL 200
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19791580
• Report Number: 8030916-2024-00038
• Device Sequence Number: 11798649
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: 010088776198191111200413
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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
• Device Model Number: 3121001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown