MAUDE Adverse Event Report: INVACARE TAYLOR ST. RELIANT 450 POWER LOW BASE LIFT 9153646735; NON-AC POWERED PATIENT LIFT

Model Number NA:RPL450-2

Device Problem Detachment Of Device Component (1104)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/25/2016

Event Type  Injury  

Manufacturer Narrative

The lift has not been returned at this time.Pictures were sent of the actuator's attachment point being broken.The patient was hospitalized for approximately 3 weeks with a pubic ramus fracture.Requests for additional information on the event, sustained injuries, medical treatment and device serial number have been unsuccessful.Should additional information become available, a supplemental record will be filed.

Event Description

Letter from a lawyer received stating his client, (b)(6), was being transferred using a patient lift.While suspended in the sling, the boom failed and ms.(b)(6) dropped three feet to the floor.Photos were provided showing the actuator failed at the point where it connects to the boom.This is a legal matter being investigated by the legal department.

Manufacturer Narrative

Evaluation found no evidence of the bushing that should be over the shoulder bolt and under the clevis.The lift is shipped from invacare and requires some assembly.  it is unknown if the bushing was installed at the time of set up or removed later.  the lift was approximately 10 years old at the time of the event.No further information has been provided about this event.Should additional information become available, a supplemental record will be filed. .

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor st.; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6603016
• MDR Text Key: 76350454
• Report Number: 1525712-2017-00024
• 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: other
• Reporter Occupation: Attorney
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

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?: Yes
• Device Operator: Other Caregivers
• Device Model Number: NA:RPL450-2
• Device Catalogue Number: RPL450-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 06/22/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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: 86 YR