Bed, Air Fluidized
Physical Medicine · 21 CFR 890.5160
Recent MDR events
1,460 adverse event reports on file
- ENVELLA BEDJul 20, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01648
- ENVELLA BEDJul 17, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01622
- ENVELLA BEDJul 17, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01631
- ENVELLA BEDJul 15, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01593
- ENVELLA BEDJul 14, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01575
- ENVELLA BEDJul 14, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01581
- ENVELLA BEDJun 29, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01476
- ENVELLA BEDJun 26, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01458
- ENVELLA BEDJun 26, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01459
- ENVELLA BEDJun 17, 2026MalfunctionBaxter Healthcare Corporation1824206-2026-01369
Event type breakdown
Recalls
9 recall events for this product code
- Hill-Rom, Inc.TerminatedMar 1, 2012
Clinitron At Home Bed headboard and foot side rails.
The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
Z-1131-2012 · View FDA record ↗ - Hill-Rom, Inc.TerminatedMar 1, 2012
Clinitron Rite Hite Bed headboard and foot side rails.
The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
Z-1132-2012 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedAug 25, 2009
CLINITRON CII Air Fluidized Therapy Units.
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Z-1902-2009 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedAug 25, 2009
CLINITRON UP-LIFT" Air Fluidized Therapy Units.
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Z-1903-2009 · View FDA record ↗ - Kinetic Concepts, IncTerminatedJul 20, 2004
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Battery outgassing of powered hospital beds
Z-0888-04 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedOct 24, 2003
Clinitron At Home Air Fluidized Therapy Unit
Power cord overheating
Z-0057-04 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedJul 10, 2003
CLINITRON CII Air Fluidized Therapy unit.
Malfunction of side-rail latching pin coupled with inadequate directions for use.
Z-0989-03 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedJul 10, 2003
CLINITRON UP-LIFT Air Fluidized Therapy unit.
Malfunction of side-rail latching pin coupled with inadequate directions for use.
Z-0990-03 · View FDA record ↗ - Kinetic Concepts, IncTerminatedApr 10, 2003
TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
Z-0718-03 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
28 clearances for this product code
- Kinetic Concepts, Inc.Jan 16, 1998
K972176 · HOME CARE BEAD BED
- Hill-Rom, Inc.May 28, 1997
K964223 · CLINITRON RITE-HITE
- Ssi Medical Services, Inc.Feb 27, 1995
K943385 · CLINITRON ELEXIS
- Ssi Medical Services, Inc.Feb 7, 1995
K942184 · CLINITRON AT HOME AIR FLUIDED THERAPY
- American Life Support Technology, Inc.Feb 17, 1994
K931168 · X-20 AIR SUPPORT BED
- Cardio Systems, Inc.Feb 2, 1994
K934689 · LOW AIR LOSS MATTRESS, MODIFICATION
- Dynamedics, Inc.Oct 15, 1993
K924973 · DYLNAMEDICS A.S.A.P.
- Ch Administration, Inc.Mar 24, 1993
K926402 · COMFORT CARE LOW AIR LOSS THERAPY BED