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

Model Number NA:GHS350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

The alleged issue of the user becoming entangled in unknown cables and falling couldn¿t be confirmed.It was unclear exactly what component was being described by ¿cables¿, but it is suspected to be the straps from the sling.It was unclear exactly what type of leg injury was sustained.However, it was indicated the user was transported to the hospital due to the injury.

Event Description

The reporter stated his wife was using the patient lift and got tangled in the cables and fell.The paramedics were called, and the cables were cut to free the user and she was transported to the hospital with an unknown leg injury.

• 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: 12016234
• MDR Text Key: 256711479
• Report Number: 9616091-2021-00006
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:GHS350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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