MAUDE Adverse Event Report: LIKO AB LIKORALL 242 S R2R, NATURAL; LIFT, PATIENT, NON-AC-POWERED

Model Number 3122011

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The technical customer support specialist was contacted by the customer, who alleged that there was sparking when removing the handset from the charging point.Upon examination of the charger, wires were still visible in void space close to the contacts.It was determined that the issue was caused by a faulty handset, a loose pin had fallen out when the handset was removed from the charging dock.The customer will replace the defective part to resolve the alleged issue.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.The instructions for use for likorall (7en120115 rev.13) states the following under inspection and maintenance: for trouble-free use, certain details should be checked each day the lift is used: inspect the lift and check to make sure that there is no external damage.Charge the batteries each day the lift is used and then check that the charger works.Although there was no injury reported, if the lifts handset was to spark while it was being removed from the mains charging dock, it could lead to serious injury or death ,therefore hillrom is reporting this event.

Event Description

The customer alleged the handset of the lift had sparking when removing it from the charging point and charging wires were visible in void space.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).

• Brand Name: LIKORALL 242 S R2R, NATURAL
• 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 Key: 18334091
• MDR Text Key: 330579552
• Report Number: 8030916-2023-00085
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3122011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• 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 Number: 1