Bed, Patient Rotation, Powered
FDA adverse event reports and recall history for bed, patient rotation, powered (product code IKZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 814
- Deaths
- 30
- Injuries
- 210
- Malfunctions
- 532
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2019-02-05TerminatedComponent design/selection
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.
- 2015-02-27TerminatedLabeling design
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2015-02-27TerminatedLabeling design
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2015-02-27TerminatedLabeling design
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2014-02-04TerminatedDevice Design
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
- 2011-05-10TerminatedDevice Design
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
- 2010-12-13TerminatedOther
RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
- 2006-02-14TerminatedOther
RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
- 2004-11-30TerminatedOther
XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.
Design control/validation deficiencies.
- 2004-07-20TerminatedOther
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Battery outgassing of powered hospital beds
Monitor bed, patient rotation, powered automatically
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