MAUDE Adverse Event Report: LIKO AB MULTIRALL 200; OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM

Model Number	3130001
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	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multirall¿ 200 overhead lift is a general-purpose lift with the intended use in: health care, intensive care and rehabilitation.Multirall 200 overhead lift is easy to move between facilities and useful for room-to-room transitions.Multirall¿ 200 overhead lift can be mounted to the rail carriage in two different ways, mounted with the lift strap under the lift unit or mounted with the lift strap above the lift unit.Intended for use in all common lift and transfer situations, for example, between bed/wheelchair, to/ from floor, toilet visits, gait training, and for horizontal lifts with stretchers.Upon inspection, the technician found the emergency stop button was out of place.Per the technician, the button came loose inside the case possibly due to an assembly fault.The field service technician repositioned the emergency button to resolve the alleged issue.The technician performed functional, visual, and audible tests per the service manual to verify the lift functioned as designed.The periodic inspection manual for overhead lifts 3en191001 lists the following instructions for check points under emergency stop: check that the emergency stop cord is secured properly and have no damage.Activate the emergency stop button.Verify that it holds and locks in the activated position.Although there was no injury reported as a result of this malfunction, a report of an emergency function not working in an operative lift could cause or contribute to a death or serious injury if the malfunction were to recur during use.
Event or Problem Description
The customer alleged the lift¿s emergency button was out of order.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: MULTIRALL 200
• Common Device Name: OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20514120
• Report Number: 8030916-2024-00070
• Device Sequence Number: 8524705
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: 00887761982284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 3130001
• 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: 10/07/2024
• Initial Report FDA Received Date: 10/23/2024
• 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
• Patient Sex: Unknown