Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIKO AB LIKORALL 242 S, WHITE; LIFT, PATIENT, NON-AC-POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIKO AB LIKORALL 242 S, WHITE; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 3122010
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Fall (1848)
Event Date 01/12/2024
Event Type  malfunction  
Event Description
It was initially reported that during a patient transfer to the armchair using the likorall 242 lift, the lift's strap dropped out of the lift, and the patient fell onto the armchair below and experienced "simple pain in the shin.During follow-up with the customer, the customer reported that this patient is an 85-year-old female (67.4 kg), and that no injury occurred with this event and no medical intervention was required.The customer reported that the patient experienced "emotional trauma" with the event.This incident was captured under hillrom complaint ref # (b)(4).
 
Manufacturer Narrative
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 the 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 rail system.Hillrom has requested for the unit to be returned to the manufacturer for investigation.In this event, no injury occurred, as reported by the customer, and no medical intervention was required.The patient was noted to have experienced emotional trauma from the event.Emotional trauma can occur as a result of a stressful event.The emotional effect can last for days or weeks but typically fades as one mentally processes the event, and does not require medical intervention.There was no injury to the patient and the patient did not require medical intervention to preclude permanent impairment of body function or permanent damage to a body structure, which concludes that a serious injury did not occur in this case.If this event were to recur (the lift strap dropping out of the lift at a length resulting in a patient fall) it is likely to result in serious injury.The exact cause of the reported event is undetermined at this time.The investigation is ongoing, any additional and relevant information that is received in the course of the investigation will be documented in a final report.
 
Manufacturer Narrative
During follow-up with the customer, the customer reported that this patient is an 85-year-old female (67.4 kg), and that no injury occurred with this event and no medical intervention was required.The customer reported that the patient experienced "emotional trauma" with the event.The device was partially returned to the manufacturer for inspection however, only the electric motor was returned.A motor shaft breakage was confirmed to be the root cause of the event.The hrc technician replaced the electrical motor to resolve the alleged issue.The technician performed a functional test per the service manual to verify the lift functioned as designed.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.In this event, no injury occurred, as reported by the customer, and no medical intervention was required.The patient was noted to have experienced emotional trauma from the event.Emotional trauma can occur as a result of a stressful event.The emotional effect can last for days or weeks but typically fades as one mentally processes the event, and does not require medical intervention.There was no injury to the patient and the patient did not require medical intervention to preclude permanent impairment of body function or permanent damage to a body structure, which concludes that a serious injury did not occur in this case.The lift was received by the manufacturer and the root cause was confirmed.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
It was initially reported that during a patient transfer to the armchair using the likorall 242 lift, the lift's strap dropped out of the lift, and the patient fell onto the armchair below and experienced "simple pain in the shin.During follow-up with the customer, the customer reported that this patient is an 85-year-old female (67.4 kg), and that no injury occurred with this event and no medical intervention was required.The customer reported that the patient experienced "emotional trauma" with the event.This incident was captured under hillrom complaint ref # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIKORALL 242 S, WHITE
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 Key18650284
MDR Text Key334665587
Report Number8030916-2024-00006
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number3122010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/12/2024
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
Patient Age85 YR
Patient SexFemale
Patient Weight67 KG
-
-