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

Model Number U3122009

Device Problems Material Deformation (2976); Device Handling Problem (3265)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

The field safety engineer who inspected the lift noted that the opening at the bottom of the charger could have exposed the user to the risk of shock.It was also noted that the device had been probably opened in past and equipped with a different supply cable.There was no allegation of patient or caregiver injury or death reported from this alleged incident.The battery charger was replaced to resolve the issue.The device functioned as designed.The electrical parts of hillrom lifts are compliant with iec (b)(4) (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 242 (7en120115 rev.13) 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¿ "the product has an expected service life of 10 years when correctly handled, serviced and periodically inspected in accordance with liko¿s instructions." this lift was manufactured 16 years ago, in 2007.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 event a reportable malfunction.

Event Description

It was reported that the lift's charger was not safe as there was an opening at the bottom.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, 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16564081
• MDR Text Key: 311774850
• Report Number: 8030916-2023-00023
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: U3122009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• 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