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

Model Number OCEAN E-VIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

This event took place in the norway with a 3-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.Further information has been requested regarding the event.If more information is received a follow-up will be filed.

Event Description

The patient was sitting in the acuatec ocean e-vip, shower chair when the screw that holds the lift/tilt arm in place fell out.The patient fell out of the chair, and broke his leg.

• Brand Name: OCEAN E-VIP
• 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 44035 ; 8003666900
• MDR Report Key: 16905811
• MDR Text Key: 314942389
• Report Number: 3007231105-2023-00001
• Device Sequence Number: 1
• Product Code: INB
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OCEAN E-VIP
• Device Catalogue Number: OCEAN E-VIP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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): Required Intervention
• Patient Sex: Male