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

Model Number 2040045

Device Problem Sparking (2595)

Patient Problem Electric Shock (2554)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

The customer reported when the viking m lift was unplugged from a wall socket panel, there was a ¿loud bang¿ and a white spark from the socket.The caregiver received an electrical shock and noted a black, charred mark on their finger.No medical intervention was required.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The hillrom service technician performed an inspection, and two out of the four wall sockets were found to have charred marks.The viking m charging cable was also noted to have a charred mark.The charging cable and extension cable were replaced as the lift was not charging.The customer was advised not to use the wall sockets until inspected by the hospital electrician.The technician also noted that the reported event was likely due to a fault of the customer's plug points' panel.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 if 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.".Although the reported event did not result in a serious injury, the report of a spark in a hospital environment could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

• 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16874707
• MDR Text Key: 314637806
• Report Number: 8030916-2023-00039
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2040045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• 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