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

Model Number	1470793KIT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On july 30, 2025, invacare was made aware of an event that occurred in canada involving an ocean vip shower chair that was also marketed in the united states.The subject device was manufactured by invacare germany, aquatec operations.Additional information has been requested regarding the alleged issue, however at this time no further information has been obtained.Without having all the relevant information, it is not possible to establish an underlying cause.The aquatec ocean vip / vip xl /dual vip shower and toilet commode user manual advises to not lean too far forwards when sitting in the shower commode and to check product regularly for damage and to ensure that the screws are firmly fitted and it is securely assembled.If additional information becomes available, a follow-up medwatch will be filed.
Event or Problem Description
It was reported a patient in an ocean vip shower chair (1470793kit) was showering with an attendant.While washing her feet, the patient leaned forward, and the seat pan disconnected from the frame.The patient fell forward onto her knees.She was sent for imaging which showed fractures to her knees that were inoperable.
Additional Manufacturer Narrative
On september 25, 2025, additional information was received.The complaint contact is unaware of when or from whom the shower chair was acquired.The contact advised the shower chair has been utilized for multiple patients and before use, a visual check is performed by the psw (personal support worker).The contact advised the shower chair is not available to be returned.The only photo received is of the serial number label.No photos have been provided of the shower chair or clarification on the incident.As the information is limited and the shower chair is not being returned, the underlying cause has not been determined.The shower chair is over eleven years old which is past the expected service life of five years as stated in the user manual.(reference aquatec® ocean vip / vip xl /dual vip shower and toilet commode user manual) if additional information is received, this incident will be reevaluated, and an follow-up will be submitted accordingly.
Event or Problem Description
It was reported a patient in an ocean vip shower chair (1470793kit) was showering with an attendant.While washing her feet, the patient leaned forward, and the seat pan disconnected from the frame.The patient fell forward onto her knees.She was sent for imaging which showed fractures to her knees that were inoperable.

• Brand Name: AQUATEC OCEAN VIP
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE AQUATEC; alemanenstrasse 10; isny
• Manufacturer (Section G): INVACARE AQUATEC; alemanenstrasse 10; isny
• Manufacturer Contact: michael simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22905066
• Report Number: 1531186-2025-00001
• Device Sequence Number: 21045547
• Product Code: ILS
• UDI-Device Identifier: 04028698096378
• UDI-Public: 04028698096378
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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?: Yes
• Operator of Device: Other
• Device Model Number: 1470793KIT
• Device Catalogue Number: 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female