MAUDE Adverse Event Report: LIKO AB GOLVO 7007 ES; NON-AC POWERED PATIENT LIFT

Model Number P2000010

Device Problems Material Frayed (1262); Material Twisted/Bent (2981)

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

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the lift strap was frayed and the gear rack was broken.In the service manual for golvo 3en400404, under the section "instructions regarding the check points, 5b base opening & closing linkage," it is stated: inspect gear rack for worn teeth and cracks where stop nut contacts back surface.Inspect friction plates.Replace if worn or damaged.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lifts.The hill-rom technician replaced the lift strap and the gear rack set to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the lift strap is twisted and fraying.The lift was located in the patient room at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: GOLVO 7007 ES
• 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: linnea hedlund ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 5307288
• MDR Text Key: 34588594
• Report Number: 8030916-2015-00165
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P2000010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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