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

Model Number RELIANT 450 PATIENT LIFT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 12/27/2022

Event Type  Death  

Event Description

A medwatch report was received from the fda.The medwatch report stated "pt had fall from hoyer lift during a transfer.He sustained an acetabular fracture with internal hemorrhaging.He died approx 15 hrs after event.".

Manufacturer Narrative

This incident will be reported in an abundance of caution.Limited information was available from the medwatch report and no contact information was available, therefore limited investigation could be conducted.The underlying cause of the user falling during a transfer and sustaining injuries and expiring 15 hours later couldn't be determined.

• Brand Name: RELIANT 450 PATIENT LIFT
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor st.; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 16371281
• MDR Text Key: 309476864
• Report Number: 1525712-2023-00002
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2023

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 Model Number: RELIANT 450 PATIENT LIFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/14/2023
• 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): Death