SARA STEDY NTB2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05055982773683), received between May 24, 2021 and Aug 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Naturally Worn; Naturally Worn

  A NEAR MISS HAS BEEN REPORTED. AS REPORTED ¿A RESIDENT SLIPPING KNEE/LEG BUMPED ON KNEE SUPPORT CAUSING BRUISING DUE TO CARPET WORN.¿

  Patient problems: Bruise/Contusion

  MAUDE report 22848263 ↗
• MalfunctionJan 15, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE RESIDENT HAD ALMOST SLIPPED SEVERAL TIMES. THE CAREGIVERS REPORTED THAT THE CASTOR BRAKES ONLY ENGAGED PERIODICALLY AND REQUESTED ARJO SERVICE. THE ARJO TECHNICIAN ASSESSED THE EQUIPMENT. THE FUNCTIONAL ASSESSMENT OF THE EQUIPMENT CONFIRMED THAT THE CASTORS AND BRAKES WERE WORKING PROPERLY. NO FAULT WAS FOUND. DURING THE INTERVIEW, THE ON-SITE SERVICE TECHNICIAN SUSPECTED THAT, DUE TO A SLIGHTLY SLOPING FLOOR, THE MACHINE MAY HAVE BEEN OPERATED WITH SOME WHEELS NOT MAKING PROPER CONTACT WITH THE FLOOR. ONCE THE RESIDENT PRESSURE WAS APPLIED, THE LIFT COULD THEORETICALLY 'SWING' SLIGHTLY TO THE POINT WHERE ALL WHEELS WERE IN CONTACT WITH THE SLOPING SURFACE. HOWEVER, THIS HYPOTHESIS CANNOT BE VERIFIED AS THE APPROPRIATE PERSON TO ASK IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156606 ↗
• MalfunctionDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE INFORMATION PROVIDED, THE PATIENT WAS TRANSFERRED USING THE SARA STEDY ACTIVE FLOOR LIFT. DURING THE TRANSFER PROCESS, THE PATIENT EXPERIENCED A CARDIAC ARREST AND THE PATIENT BECAME UNCONSCIOUS WHILE SITUATED WITHIN THE SARA STEDY ACTIVE FLOOR LIFT EQUIPMENT. AS A CONSEQUENCE OF THE EVENT THE PATIENT SLUMPED FORWARDS OVER THE LIFT FRONT BAR, BUT WITH ENOUGH WEIGHT STILL ON THE SEAT FLAPS TO PREVENT THEM BEING MOVED. NO INJURY WAS REPORTED. THE DEVICE WAS EVALUATED BY AN ARJO REPRESENTATIVE AND NO MALFUNCTION WAS FOUND.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354844 ↗
• MalfunctionFeb 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPOTTED THAT DURING TRANSFER PATIENT FELL OUT FROM THE DEVICE. THERE WAS NO INJURY REPORTED. THE CUSTOMER STATED THAT THE CASTOR BRAKES WERE NOT WORKING. AFTER THE EVENT THE ARJO REPRESENTATIVE TESTED THE DEVICE. THE DEVICE EVALUATION REVEALED THAT THE CASTOR BRAKES ARE HARD TO LOCK AND MORE FORCE IS NEEDED TO LOCK THE BRAKES. THE BRAKES WERE REPLACED. THE BRAKES MALFUNCTION BY ITSELF DID NOT CAUSE THE PATIENT FALL. DURING INTERVIEW THE CUSTOMER DENIED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING EVENT CIRCUMSTANCES. IT WAS NOT POSSIBLE TO DETERMINE THE COURSE OF EVENTS LEADING TO PATIENT FALL.

  Patient problems: Fall

  MAUDE report 16275945 ↗
• InjuryMay 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF THE SARA STEDY ACTIVE LIFT, WHICH WAS REPORTED BY THE FAMILY MEMBER OF THE INVOLVED PERSON. THE PATIENT (APPROXIMATELY 6'2" IN HEIGHT) WAS ATTEMPTING TO USE THE LIFT, WHEN HE SLIPPED/FELL BACKWARDS OFF THE DEVICE. THE PATIENT SUSTAINED A FEW BRUISES AND SCRAPPED HIS SHINS. ACCORDING TO THE PROVIDED INFORMATION, THE PERSON INVOLVED WAS NOT HOSPITALIZED.

  Patient problems: Abrasion; Bruise/Contusion; Fall

  MAUDE report 11869684 ↗