MAUDE Adverse Event Report: INVACARE TAYLOR STREET INVACARE RELIANT 450 BATTERY-POWERED LIFT; LIFT, PATIENT, AC-POWERED

Model Number RPL450-1

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The dealer provided a photograph of the electric actuator.The photograph shows that the mounting holes on the shaft extension of the actuator are worn through, which would result in the actuator becoming detached from the boom at the mounting bracket, as described.The lift was returned to invacare for an evaluation, and it was identified that the bushing, as well as the finger guard, were missing from the actuator assembly.This likely caused excessive play in the actuator end, that over time caused wear and lead to the actuator end breaking.It has been determined that the cause of the failure in aging devices (outside of their 8-year life expectancy, as is the case for this lift) is likely due to improper maintenance and/or placement of the bushing during initial assembly/maintenance by the purchaser of the lift.If the bushing is not in place then the metal-to-metal contact, between the shaft extension of the actuator and the shoulder bolt, will cause wear after considerable use.Review of current packaging confirmed that the bushing is assembled onto the shoulder bolt/nut on the lift boom when shipped from invacare's manufacturing site.The maintenance safety inspection checklist within the lift owner's manual instructs to inspect the hardware connecting the actuator assembly to the mast and boom and to check for wear or deterioration on a monthly basis.Any defective parts should be replaced immediately.

Event Description

The dealer reported that her customer alleged that two certified nursing assistants were transferring the patient from a bed to a chair, and the rpl450-1 lift failed causing the patient to fall.The patient was sore following the incident but did not require any medical intervention.The facility indicated that the failure occurred where the actuator attaches to the boom of the lift; the bolt fell out and now the boom will not hold in a vertical position.

• Brand Name: INVACARE RELIANT 450 BATTERY-POWERED LIFT
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7248218
• MDR Text Key: 99330921
• Report Number: 1525712-2018-00013
• Device Sequence Number: 1
• Product Code: FNG
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/08/2018

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: Nursing Assistant
• Device Model Number: RPL450-1
• Device Catalogue Number: RPL450-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2005
• 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 Age: 99 YR
• Patient Weight: 127