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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIKO AB MULTIRALL 200; LIFT, PATIENT, NON-AC-POWERED
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LIKO AB MULTIRALL 200; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 3130001
Device Problems Defective Component (2292); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2023
Event Type  malfunction  
Event Description
The customer alleged that the multirall's lifting strap was faulty, pin dropped out due to deformation of the plastic cover and wires exposed on hand control.This report was filed in our complaint handling system as (b)(4).
 
Manufacturer Narrative
The device was inspected and repaired by a third-party technician.The technician and the customer have been contacted for further information on the reported event.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
 
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 hillrom service technician found that the attachment from strap to q-link was attached incorrectly.The hillrom service technician reattached the strap to the q- link to resolve the issue.The hillrom service technician performed a functional test as per the service manual to verify the unit functioned as designed.Based on this information no further actions are required.
 
Event Description
The customer alleged that the multirall's lifting strap was faulty, pin dropped out due to deformation of the plastic cover and wires exposed on hand control.This report was filed in our complaint handling system as (b)(4).
 
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Brand Name
MULTIRALL 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 Key16731089
MDR Text Key313195345
Report Number8030916-2023-00029
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number3130001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2023
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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