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

Model Number NA:GHS350

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

This incident is being reported due to the allegation that the device malfunctioned resulting in the user being transported to the hospital with unknown injuries.Multiple attempts were made to obtain further details and a return of the device.However, at this time the reporter hasn't responded to any of the attempts.The device was roughly 5 years old at the time of this incident.The manual has multiple statements regarding maintenance and care that are relevant to this incident.Based on the available information its unclear if maintenance and inspection requirements were followed.The pictures provided appear to confirm the damage to the leg brackets.The damage appears consistent with wear that would have occurred over time.The underlying cause of the damage couldn¿t be determined.This incident will continue to be investigated and should further information become available that changes the current findings a follow up medwatch will be filed.

Event Description

The reporter stated the brackets on the legs wore through and the user fell to ground.The user put a hole in the wall during the incident.The user was transported to the hospital by emergency services.

• 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: 16919420
• MDR Text Key: 315094723
• Report Number: 9616091-2023-00008
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:GHS350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/12/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female