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

Model Number NA:GHS350

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The reporter alleged the patient lift was wobbly and wouldn't lock in place.They stated one hinge plate was 3/4 worn through and the other was completely cracked.They stated a patient was using the lift during this issue and almost fell but didn't.

Manufacturer Narrative

This issue is being reported due to should it recur there is a likelihood of resulting in serious injury/death.There was no allegation of injury related to this incident.The issue would be easily detectable as it would prevent the lift legs from locking in place.This device was over 5 years old at the time of this incident.Based on the available information it¿s unclear if maintenance and inspection requirements were followed.The manual has multiple statements regarding maintenance and care that are relevant to this incident.Pictures were provided which confirmed one of the hinge plates was almost completely worn through and another picture appeared to show the crack alleged.However, the reporter was unable to provide better pictures showing the alleged crack.The damage appears consistent with wear that would have occurred over time.The manual for this device has the following statements that are relevant to this incident.¿it is important to inspect all stressed parts, such as slings, sling attachment knobs, and any pivot for slings for signs of cracking, fraying, deformation, or deterioration.Replace any defective parts immediately and ensure that the lift is not used until repairs are made.¿ the inspection checklist states the base should be checked that it opens/closes with ease, inspect roll pin to ensure its secure to the base, adjustable base locks when engaged, and inspect roll pin for wear.

• Brand Name: GET-U-UP HYDRAULIC STAND-UP LIFT 9153648036
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18005585
• MDR Text Key: 326521738
• Report Number: 9616091-2023-00021
• 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: Other
• Type of Report: Initial
• Report Date: 10/25/2023

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: Health Professional
• Device Model Number: NA:GHS350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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