Aquatec Ocean -VIP Kit Series 1470000Recalls & reported problems
Invacare Corporation · Basic US Model Ocean-VIP Kit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04028698096378), received between Jan 6, 2025 and Aug 27, 2025 — classified as 1 death, 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Device Tipped Over1
Patient problems
- Bone Fracture(s)2
- Intracranial Hemorrhage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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.
Patient problems: Bone Fracture(s)
MAUDE report 22905066 ↗DeathJan 10, 2025Device Tipped Over; Device Tipped Over
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.
Patient problems: Intracranial Hemorrhage
MAUDE report 21123447 ↗InjuryJan 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
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.
Patient problems: Bone Fracture(s)
MAUDE report 21082150 ↗
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- Raz Raz-CATRaz Design Inc · Chair, Adjustable, Mechanical2 reports
- DRIVEMEDICAL ATC17-BKDrive Devilbiss Healthcare · CHAIR, ADJUSTABLE, MECHANICAL1 report
- Staxi ST010Three Bears(Jiangsu)Healthcare Technology CO.,Ltd · Chair, Adjustable, Mechanical1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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