MAUDE Adverse Event Report: LIKO AB LIKO M230; LIFT, PATIENT, NON-AC-POWERED

Model Number 2050015

Device Problem Sparking (2595)

Patient Problem Blister (4537)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

As confirmed by the customer, there was no issue with the lift and the issue was caused by a damaged charging cable.The problem had already been identified by the user and the cable had been removed from service.The charging cable was 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 mobile lifts (3en371001 rev.5) under section 8: verify that all cables are properly inserted.Re-insert if uncertain.Verify battery charge by inspecting the charger indicator.Check cables and connectors for damage or wear." in the instruction manual for liko m230 (7en150106 rev.10) 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.Electric shock occurs upon contact of a (human) body part with any source of electricity that causes a sufficient current through the skin, muscles, or hair.Shock injury is relative to the magnitude of current the body is exposed to, individual body impedance, and area of exposure.A blister resulting from a burn is characterized as a bubble of clear fluid under the skin.Treatment for burn blisters varies based on the severity of the underlying burn.Basic first aid can help for mild cases such as running the area under cool water, applying ointment and a bandage.The reported shock and subsequent injury could be contributed to the use of the damaged power cord, as acknowledged by the customer as the power cord was packed for return and labeled as "damaged" and had been removed from service.Additionally, the reported blister with no medical intervention indicates that a serious injury did not occur.Although the reported event did not result in a serious injury, the report of a charging cable sparking during charge could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.Charging cable discarded by the customer.

Event Description

Hillrom received a customer report stating: carer reported to ices office that mobile hoist was not working and a spark was seen when trying to place the hoist on charge.Ices driver/fitter requested to attend clients property by ices office to test hoist functions and report any damage.Ices driver/fitter tested operation of hoist to find hoist operation to be normal.However despite the charger being in a bag for return and damaged the ices driver/fitter plugged mains cable into charging point of hoist and received an electrical shock resulting in a blister forming on the ices driver/fitters finger - no medical treatment required.Hoist regularly serviced, last serviced 17/2/2021, loler tested on (b)(6) 2021 - figure of 8 power lead had a small split that was not observed by ices driver/fitter when plugged into electrical mains causing an electrical shock.Driver asked to test the hoist by means of battery to negate the need to replace the entire hoist if it was just a supply lead fault.Not asked to test via the mains supply in patients home.There is no fault with the hoist.It was a charging cable that was faulty.The lift was located at the account at the time of the incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKO M230
• 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: 14051177
• MDR Text Key: 298497684
• Report Number: 8030916-2022-00019
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2050015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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