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

Model Number 2040035

Device Problem Sparking (2595)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician inspected the lift and found that the extension cable was burned and the lift was not working.The extension cable, charging cable, battery and control unit were all replaced and the lift was 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 as 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) it is stated 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 viking lifts (7en137107 rev.4) 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." and on page 14, under charging the battery section: " if the charger cable (coiled cable) is beginning to stretch, it should be replaced in order to minimize the risk of the cable getting stuck and breaking." if the instruction as outlined above are followed it is very unlikely for an injury to occur due to this error.Although the reported event did not result in a serious injury, the report of sparking could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

The customer alleged the built-in charger was sparking.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: VIKING M
• 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: 17197436
• MDR Text Key: 318243058
• Report Number: 8030916-2023-00049
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2040035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• 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