MAUDE Adverse Event Report: AQUATEC OCEAN VIP ERGO; ATTACHMENT, COMMODE, WHEELCHAIR

Model Number 1643738

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

This event took place in sweden with a 1-year old aquatec ocean vip ergo shower commode.It is being reported due to the aquatec ocean vip ergo shower commode is also sold in the united states.The affected aquatec ocean vip ergo commode nor the footrests, heel straps or calf straps were returned for investigation.Pictures of the device were received.The pictures showed that the heel straps and calf straps were present on the device.Although both straps were installed on the commode, the patient still managed to move his foot over the heel strap, past the calf strap to the back and finally under the metal tube of the footrest.From the pictures it cannot be determined if the straps were installed correctly or if they were in the proper position for the end user.The heel straps and the calf strap are intended to ensure that the patient's feet are securely positioned on the plates of the footrests during the use of the device.It is very unlikely that a patient gets in contact with the lower ends of the metal tubes of the footrests during normal and intended use of the device, especially if the heel straps are installed and adjusted correctly for the patient.Factors contributing to the incident could include: the end user¿s pre-existing condition with spasticity, the heel straps, calf straps or other parts of the device, were not correctly adjusted or fitted for the specific needs of this patient.

Event Description

The patient with spasticity managed to lift his foot (over the heel ban) and back, causing his heel to hit the bottom of the metal tube of the footrest resulting in a wound requiring sutures.

• Brand Name: OCEAN VIP ERGO
• Type of Device: ATTACHMENT, COMMODE, WHEELCHAIR
• Manufacturer (Section D): AQUATEC; 8 am achener hof; isny 88316 ; GM 88316
• Manufacturer (Section G): AQUATEC; 8 am achener hof; isny 88316 ; GM 88316
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 15626908
• MDR Text Key: 301944566
• Report Number: 3007231105-2022-00002
• Device Sequence Number: 1
• Product Code: INB
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1643738
• Device Catalogue Number: NA:OCEAN VIP ERGO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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
• Patient Weight: 60 KG