MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TOTALCARE BARIATRIC PLUS BED; BED, FLOTATION THERAPY, POWERED

Model Number	P1840R
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that tc bariatric plus w/ air had head of bed not going up.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter service technician found that patient was laying to high in the bed.The patient was moved towards the foot of the bed to resolve the reported event.Based on this information, no further action is required.The ifu advised the customer to follow the below information for the proper placement of the patient: -the hip position label indicates the correct position of the patient¿s hips while on the bed.The labels are on the inside of the intermediate siderail just below the head up/down controls on the patient control panel.

• Brand Name: TOTALCARE BARIATRIC PLUS BED
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25386135
• Report Number: 1824206-2026-01279
• Device Sequence Number: 20143760
• Product Code: IOQ
• UDI-Device Identifier: 00887761000865
• UDI-Public: (01)00887761000865(11)061116
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: P1840R
• Device Catalogue Number: P1840RE200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown