MAUDE Adverse Event Report: INVACARE GMBH OCEAN VIP; ADAPTOR, HYGIENE

Model Number	OCEAN VIP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user had just showered with the help of two people and needed help with drying.The staff tilted the ocean vip shower commode chair forward and then leaned the end user forward to wipe their back.The end user slides forward, falls to the floor and the chair falls over him.The incident resulted in the end user sustaining a distal femur fracture.
Additional Manufacturer Narrative
Invacare was made aware of an event that occurred in sweden with an 8-year-old aquatec ocean vip shower chair.This medwatch is being filed in an abundance of caution due to the aquatec ocean ergo shower chair being sold in the us and would likely have the same outcome if this event were to occur.With the available information this event appears to be user error with no alleged malfunction of the shower chair.There was no additional anti-tip protection installed at the time of the incident and no belt or chest harness was used.The aquatec ocean vip ergo/aquatec ocean dual vip ergo user manual provides a warning, risk of tipping, ¿do not lean excessively forwards.¿.

• Brand Name: OCEAN VIP
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE GMBH; am achener hof 8; isny 88316 ; GM 88316
• Manufacturer (Section G): INVACARE AQUATEC; am achener hof 8; isny 88316 ; GM 88316
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 21082150
• Report Number: 3007231105-2025-00001
• Device Sequence Number: 15537219
• Product Code: ILS
• UDI-Device Identifier: 04028698096378
• UDI-Public: (01)04028698096378
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: OCEAN VIP
• Device Catalogue Number: AQUATEC OCEAN VIP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown