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

Model Number P2000010

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the gear rack and friction plate needed replaced.In the service manual for golvo 3en400404, under the section instructions regarding the check points, 5b base opening and 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 technician replaced the gear rack and friction plate 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 leg came out of the lower base.The lift was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (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: jesper lundstrom ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 6945883
• MDR Text Key: 90407156
• Report Number: 8030916-2017-00058
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 09/28/2017

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: P2000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1