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

Model Number 1644814

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

Patient Problem Insufficient Information (4580)

Event Date 08/21/2022

Event Type  Injury  

Manufacturer Narrative

This event that took place in the united kingdom it is being reported due to the aquatec ocean vip ergo shower commode is also sold in the united states.Invacare has been informed about an incident with an aquatec ocean vip ergo shower commode.The patient was sitting in the shower-chair waiting to be hoisted, the individual bent forward when the shower-chair tipped forwards.The individual was restrained by the chest belt and it is possible the footrests prevented the chair from toppling fully over.We have been also informed that hospital treatment for the patient was required but the type of injury and the type of treatment was not disclosed.Further information has been requested regarding the injury and what, if any malfunction occurred.If any further information is received a follow-up will be filed.

Event Description

The patient was sitting in the aquatec ocean ergo vip shower chair.The individual bent forward when the shower-chair tipped forward.The individual was restrained by the chest belt and it is possible the footrests prevented the chair from toppling fully over.Hospital treatment was required.Type of injury: not disclosed.

• 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; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 15536955
• MDR Text Key: 301114621
• Report Number: 3007231105-2022-00001
• Device Sequence Number: 1
• Product Code: INB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1644814
• Device Catalogue Number: AQUATEC OCEAN ERGO VIP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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