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

Model Number VIKING XL

Device Problems Material Integrity Problem (2978); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

It was reported to hill-rom that during the transfer of a pt the sling was torn apart.No info provided regarding pt impact.Mfr ref# 8030916-2014-00024.

• Brand Name: VIKING
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea 975 92; SW 975 92
• Manufacturer (Section G): HILL-ROM, INC.; 125 east pearl st.; batesville IN 47006
• Manufacturer Contact: 125 east pearl st.; batesville, IN 47006
• MDR Report Key: 3754147
• MDR Text Key: 4418241
• Report Number: 1824206-2014-00995
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014,03/11/2014

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: Other
• Device Model Number: VIKING XL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2014
• Distributor Facility Aware Date: 03/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1