Recalls for Bed, Flotation Therapy, Powered

The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.

There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.

Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.

Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.

There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi

When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.

In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,

The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.

Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.

Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.

Power cords may crack and fail inside plug with potential for fire hazard.

Power cords may crack and fail inside plug with potential for fire hazard.

The devices may emit smoke from the blower box assembly.

The devices may emit smoke from the blower box assembly.

A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.

Weld failure causes side rail welds to turn upside down or break off of the bed.

Battery outgassing of powered hospital beds

Reports of patient entrapment between mattress and side-rails.

Reports of patient entrapment between mattress and side-rails.

Battery Failure/ Outgassing

Battery Failure/ Outgassing

Battery Failure/ Outgassing

Battery Failure/ Outgassing

Battery Failure/ Outgassing

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.