MAUDE Adverse Event Report: LIKO AB LIKORALL 200; LIFT, PATIENT, NON-AC-POWERED

Model Number 3121001

Device Problems Fracture (1260); Device Handling Problem (3265)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

The reported issue was discovered during a technician inspection requested by the customer.It was confirmed that the charging cable that goes from the wall outlet into the lift's charging pod had exposed copper wires, as they had been inadvertently trapped behind the aluminum plate that holds the charger and the sling bar hook.The customer confirmed the reported event was caused by an incorrect handling of the device.There was no allegation of patient or caregiver injury or death reported from this alleged incident and the lift was working and charging appropriately when the damage was found.The charging cable and the charging pod were replaced to resolve the issue.The lift is functioning as designed.The electrical parts of hillrom lifts are compliant with iec 60601-1 (medical electrical equipment - part 1: general requirements for basic safety and essential performance) which applies to the basic safety and essential performance of medical electric equipment and medical electric systems.Even though all hillrom lifts comply to the above mentioned electrical standard, there is still a risk that abnormal wear and tear can damage the cables.Therefore, hillrom states in the periodic inspection manual for liko overhead lifts (3en191001 rev.2) under section 4 and 8: " access to the mains connections must not be blocked and have no damage.Check cord for exposed wear or tear in the insulation sleeve.Inspect casing for damage, verify dust & water seal is intact." in the instruction manual for likorall 200 (7en120114 rev.11) states, under inspection and maintenance section: "a periodic inspection of the lift should be carried out at least once per year.Periodic inspection, repair and maintenance may be performed only in accordance with the liko service manual by personnel authorized by hillrom and using original liko spare parts." ¿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.¿ if the instruction as outlined above are followed it is unlikely for an injury to occur due to this error.Although the reported event did not result in a serious injury, the report of exposed copper wires in a lift's charging cable could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

It was reported that the lift's charging cable that goes from the wall outlet into the charging pod had a small cut, exposing copper wires.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 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15630574
• MDR Text Key: 307069314
• Report Number: 8030916-2022-00051
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3121001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/19/2022
• 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