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

Model Number	3130001
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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.Hillrom has requested the device to be returned for investigation.Investigation into the reported incident is currently ongoing.All additional and relevant information that is identified following completion of the review will be submitted in a supplemental report.
Event or Problem Description
The customer alleged the lift had bent rods on the internal motor, causing the motor to tighten and the fuse to be blown.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).
Event or Problem Description
The customer alleged the lift had bent rods on the internal motor, causing the motor to tighten and the fuse to be blown.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).
Additional Manufacturer Narrative
The motor was returned to the manufacturer for investigation where it was determined that one of the centrifugal brake hooks had come out from its intended position inside the motor.This was caused by the fact that the spring that should hold it in place had been damaged/deformed.When this malfunction occurs, the sudden downward movement will activate the sfs and bring the movement of the lift to a complete stop.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.A report of motor shaft breakage would be unlikely to cause or contribute to a death or serious injury, if the malfunction were to recur as the device has a secondary system that becomes activated and prevents the patient from falling in case the primary system fails.The device meets the requirement for a secondary system with a safety function that stops the patient¿s movement downwards, in the event of a motor or transmission failure.This safety design provides protection against uncontrolled lowering.There are no risks identified for this failure due to the single fault system.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.Hillrom does not consider this complaint to be a reportable malfunction.

• Brand Name: MULTIRALL 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: 19748881
• Report Number: 8030916-2024-00034
• Device Sequence Number: 6607387
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: 010088776198228411210504
• 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,Followup
• Report Date (Section B): 08/13/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/13/2024
• 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