MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER LIFT W/LOW BASE-PLUS 9153633519; LIFT, PATIENT, NON-AC-POWERED

Model Number RPL450-1

Device Problem Bent (1059)

Patient Problem Fall (1848)

Event Date 09/06/2010

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The lift was received and inspected.Several components were damaged, broken, modified and worn.The spreader bar was damaged and modified and would not fasten to the lift.The actuator pinch guard was missing.When standing in the operator position, the left side of the mast to boom clevis shows an attempted repair by welding.One leg was inoperable and the legs would not remain in the locked position due to a detached rod.The rod can be seen on the ground under the lift, and the emergency stop button was broken off the lift.Instability would be experienced from this lack of maintenance.Incident is due to a lack of maintenance, unauthorized modifications, and broken components.

Event Description

The facility alleges the pin that holds the arm stationary that connects the boom to the mast bent, causing the lift to tip sideways and the resident fell to the ground.No serious injury is alleged.

• Brand Name: POWER LIFT W/LOW BASE-PLUS 9153633519
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5688637
• MDR Text Key: 46198328
• Report Number: 1525712-2016-01430
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/08/2010

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: Lay User/Patient
• Device Model Number: RPL450-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2010
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2010
• Initial Date FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 82
• Patient Weight: 91