MAUDE Adverse Event Report: UNKNOWN RELIANT 450 POWER LOW BASE LIFT 9153646735; LIFT, PATIENT, NON-AC-POWERED

Model Number RPL450

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 05/15/2016

Event Type  Injury  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.There is no malfunction associated with the alleged injury.User¿s manual review (1078987 rev.L, page 7) warning - do not use this product or any available optional equipment without first completely reading and understanding these instructions and any additional instructional material such as owner¿s manuals, service manuals or instruction sheets supplied with this product or optional equipment.If you are unable to understand the warnings, cautions or instructions, contact a healthcare professional, dealer or technical personnel before attempting to use this equipment - otherwise, injury or damage may occur.

Event Description

End user's daughter advised has cameras in her mother's room at the facility.End users daughter advised mother is not able to bend at knees.End users daughter advised mother's feet were to the left in the sling and should have been to the right, so employees forced legs to get through bar, so legs would be on the right side.End users daughter advised right foot and ankle are bruised no fault of the lift.End users daughter is looking for a video, so staff is properly trained.End users daughter will contact a local provider to get a training video.End users daughter advised facility advised they have properly trained their workers.End users daughter could not provide any further information.End users daughter advised in house x rays were taken at the facility.Update from consumer affairs on 6/13/2016: facility is working with her to be sure the staff is trained to transfer properly.She feels that her moms legs were on the wrong side of the mast, like all of her weight was to one side causing her to be lopsided.She states there is no alleged malfunction and the lift is in good working order.She feels it is the staff not transferring her mom properly that was the cause of the alleged incident.No further information available.

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5737767
• MDR Text Key: 47806098
• Report Number: 1525712-2016-01980
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RPL450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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