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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIKO AB VIKING M; NON-AC POWERED PATIENT LIFT
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LIKO AB VIKING M; NON-AC POWERED PATIENT LIFT Back to Search Results
Model Number 2040035
Device Problem Device Slipped (1584)
Patient Problem No Patient Involvement (2645)
Event Date 02/04/2019
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the repair of the lift at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Hill-rom received a report from the account stating the lift arm of the mobile lift dropped during transfer of the patient.The lift was located at the account at the time of the incident.There was no patient or user injury but the patient became afraid.This report was filed in our complaint handling system as (b)(4).
 
Manufacturer Narrative
The customer has decided to not do any repairs on this product.The most probable root cause to the event is users have lifted the lift arm assembly manually.A field safety corrective action, mod1228, was initiated in march 2015.Mod1228 informed the customer that the lift arm assembly is intended to only be lifted by the actuator (lift motor) and performed a physical inspection of potentially affected devices and add a sticker to the lift portraying how users shall not manually lift the lift arm manually.At the healthcare facility in this event, ehpad saint maur, the mod1228 was performed on the (b)(6) 2016 and 4 lifts where inspected.
 
Event Description
Hill-rom received a report from the account stating the lift arm of the mobile lift dropped during transfer of the patient.The lift was located at the account at the time of the incident.There was no patient or user injury but the patient became afraid.This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
VIKING M
Type of Device
NON-AC POWERED PATIENT LIFT
Manufacturer (Section D)
LIKO AB
nedre vagen 100
lulea, norrbottens lan [se-25] 975 9 2
SW  975 92
MDR Report Key8389778
MDR Text Key137847848
Report Number8030916-2019-00014
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2040035
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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