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

Model Number GOLVO 7007 ES

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

It was reported to hill-rom that whilst inspecting the lift the handle's attachment point on the mast came loose when the lift was operated.No patient impact.Mfr - 8030916-2014-00028.

• Brand Name: GOLVO
• 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: 3808515
• MDR Text Key: 4384775
• Report Number: 1824206-2014-01024
• Device Sequence Number: 1
• Product Code: FSA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/28/2014,03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GOLVO 7007 ES
• Device Catalogue Number: 2000010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Distributor Facility Aware Date: 03/05/2014
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1