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

Model Number	OCEAN VIP
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/02/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Invacare was made aware of an event that occurred in sweden involving an ocean vip mobile shower chair.Invacare is filing this medwatch in an abundance of caution due to the ocean vip shower chair is sold in the u.S.The subject device was manufactured by invacare germany, aquatec operations.The shower chair has been disposed of and no photos are available.The reported advised the anti-tippers and optional pelvic and chest belts were not installed on the shower chair.A malfunction of the device was not alleged, and the event may be the result of the use error.It was also noted it could not be determined if the cerebral hemorrhage was due to the patient¿s medical history or the result of the fall.
Event or Problem Description
It was reported a fall occurred from an ocean vip shower chair in the bedroom when the sling was being removed by an assistant.The shower chair tipped forward, and the patient fell towards the closet door and hit his head.After the incident, the patient did not want to go to the hospital according to the assistant.The patient has regular contact with the health care provider as he receives dialysis three times a week.After 5 days, the patient's condition deteriorated, and level of consciousness decreased.When the prescriber followed up on the incident the following week, it was discovered that the patient was hospitalized with a cerebral hemorrhage and treatment had been terminated.The patient died on (b)(6) 2024.

• Brand Name: OCEAN VIP
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE GMBH; 8 am achener hof; isny 88316 ; GM 88316
• Manufacturer (Section G): INVACARE GMBH; 8 am achener hof; isny 88316 ; GM 88316
• Manufacturer Contact: michael simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 21123447
• Report Number: 3007231105-2025-00002
• Device Sequence Number: 7538805
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: Other
• 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: 12/16/2024
• Initial Report FDA Received Date: 01/10/2025
• 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: Death
• Patient Sex: Male