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

Model Number 2000010

Device Problem Failure To Service (1563)

Patient Problem Laceration(s) (1946)

Event Date 11/07/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating that on (b)(6) 2014 the staff was moving a patient in the lift from wheel chair to bed and the patient slipped out of the sling and fell to the floor.The lift was located in the patient room.The patient sustained laceration on the back of her head and a broken hip.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Lift had exceeded its expected lifetime at the time of the event.The sling used was a soft original highback, size medium.The field investigation showed that the product had wear on the liftstrap.A 12 inch long entwining of the liftstrap.Technician suggested replacement per manufacturers preventive maintenance guidelines.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this lift in (b)(6) 2014.No further information is available on the repair of the lift at this time.The investigation is on going, however, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: GOLVO 7007 ES
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedrevagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: nazanin bitaraf ; nedrevagen 100; lulea SE-97-5 92 ; SW SE-975 92 ; 20474700
• MDR Report Key: 4332006
• MDR Text Key: 18039548
• Report Number: 8030916-2014-00115
• 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: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2004
• 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
• Patient Outcome(s): Hospitalization