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

Model Number 2000010

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician inspected the lift and found it functioned as designed.The account confirmed that the caregiver misused the lift causing the incident to occur.According to the instruction guide for the golvo lift, the lift's wheels shall be placed under the bed , so the center of gravity is directly under the sling bar.The lift is in proper working order.Based on this information, no further action is required.

Event Description

Hill-rom received medwatch #5059973 from the fda stating the staff member at the account wedged the lift under the patient's bed while lifting the patient.The staff member forced the lift to rise until the tension caused the leg to break and the lift to turn over.The patient fell to the floor and sustained a spiral fracture of the right femur.The patient's leg was splinted and wrapped until a cast was applied.The lift was located at the account at the time of the incident.(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: 5548350
• MDR Text Key: 41908642
• Report Number: 8030916-2016-00046
• 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: Other
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2000010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 90