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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIKO AB LIKORALL 200; LIFT, PATIENT, NON-AC-POWERED
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LIKO AB LIKORALL 200; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 3121001
Device Problems Break (1069); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Manufacturer Narrative
The unit has been returned to the manufacturer for inspection into the reported malfunction.Investigation is currently on going.All additional and relevant information that is identified following completion of the investigation will be submitted in a supplemental report.
 
Event Description
The customer alleged the lift strap was releasing with load.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).
 
Manufacturer Narrative
The unit was returned to the manufacturer for inspection where a motor shaft breakage was confirmed.It was additionally noted that the sfs was found to be working as intended.The lift was replaced for the customer.Likorall overhead lift is intended for use in, health care, intensive care and rehabilitation.Likorall overhead lift is designed for fixed installation and free-standing lift systems.All common lifts and transfers can be performed using likorall overhead lift, for instance between bed/wheelchair, to/from floor, toilet visits, gait training, and together with stretchers.Likorall r2r (room to room) overhead lift enables the patient to be moved between two rail systems in separate rooms.Likorall overhead lift with the es designation is prepared for operation with the wireless handcontrol remote (ir) and in addition, a transfer motor can be connected for motor driven movement along the rail.Likorall s, irc overhead lift is prepared for continuous charging through the railsystem.As per iso 10535 it is acceptable to have a secondary system that becomes activated and prevents the patient from falling in case the primary system fails.Hillrom has met the requirement for a secondary system with a safety drum that lowers the patient to the surface in a controlled and safe manner, in the event of a motor or transmission failure.This patented safety design provides protection against uncontrolled lowering.The lift was received by the manufacturer and the root cause was confirmed.The sfs system was tested and it worked as intended.In the reported event, there was no report of serious injury or death and should a similar malfunction recur, it is unlikely to cause a serious incident for the reason stated above.Therefore, hillrom does not consider this complaint reportable.
 
Event Description
The customer alleged the lift strap was releasing with load.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).
 
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Brand Name
LIKORALL 200
Type of Device
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 Key18695267
MDR Text Key335323938
Report Number8030916-2024-00008
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number3121001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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