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

Model Number 2040045

Device Problem Sparking (2595)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician and engineers reviewed a picture of the affected cable and were able to confirm that there was damage in the cable insulation.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, revision 4) it is stated under section 8: check cables and connectors for damage or wear.In the instruction manual for viking lifts (7en137107, revision 4) it is stated on page 4: before lifting, always make sure that: the lifting accessories are not damaged.And on page 14: 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 instructions as outlined above are followed, it is very unlikely that an injury could occur due to this error.A replacement cable has been ordered for the account to resolve the issue.Hillrom continuously monitors all complaint trends to identify any additional issues and initiates appropriate actions as per our quality management system.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account that the extension cable had burnt.The device was located at the account there was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: VIKING M
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 11605500
• MDR Text Key: 245081983
• Report Number: 8030916-2021-00013
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2021

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 Operator: No Information
• Device Model Number: 2040045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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