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

Model Number LIKORALL 242 S

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

It was reported to hill-rom that a lift strap was ripped.No more info provided to this date.No pt impact reported.Mfr ref # 8030916-2014-00023.

• Brand Name: LIKORALL
• 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: 3754174
• MDR Text Key: 4415663
• Report Number: 1824206-2014-00991
• 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: 03/25/2014,02/25/2014

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: LIKORALL 242 S
• Device Catalogue Number: 3122009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2014
• Distributor Facility Aware Date: 02/25/2014
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 03/25/2014
• 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