MAUDE Adverse Event Report: INVAMEX GET-U-UP HYDRAULIC STAND-UP LIFT 9153648036; LIFT, PATIENT, NON-AC-POWERED

Model Number NA:GHS350

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

The dealer advised due to the lift tipping over the legs of the lift would not fully open.It is unclear why the lift tipped over.Attempts have been made to contact the provider and consumer for additional information.The provider did not have any additional information, and the consumer has not returned our calls.This device was over 4.5 years old at the time of this incident.Based on the available information the lift was last serviced october 2021.If additional information becomes available a follow-up will be filed.

Event Description

The home healthcare worker was transferring the patient from the bed to a chair using a 4-1/2-year-old ghs350 lift.Unfortunately, the lift tipped over, resulting in the patient breaking their hip.As a result, the patient had to be hospitalized, and while in the hospital, they developed sepsis.It is unclear if the patient underwent surgery and which hip was broke.Dealer advised their tech went out to look at the lift and noticed legs were more narrow than normal, and he could not get them to open to the normal width.The tech then removed bottom plate on the back of the lift exposing the leg connection and found metal shavings and half of the metal was ground away.Dealer advised family or caregiver did not notice any issues with the lift.

• Brand Name: GET-U-UP HYDRAULIC STAND-UP LIFT 9153648036
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18086739
• MDR Text Key: 327558058
• Report Number: 9616091-2023-00023
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA:GHS350
• Device Catalogue Number: GHS350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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): Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 111 KG