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

Model Number	P1840D
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that totalcare bariatric capital head section could not be raised.The bed was located at the account and the process step at which the issue occurred was not specified.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test on the total care head section.The baxter technician thoroughly inspected the bed and was unable to duplicate the reported issue.The bed functioned as designed.However, if the reported event of a total care head section not going up were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.

• 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: 25623212
• Report Number: 1824206-2026-01444
• Device Sequence Number: 10194306
• Product Code: IOQ
• UDI-Device Identifier: 00887761000865
• UDI-Public: (01)00887761000865(11)131002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: P1840D
• Device Catalogue Number: P1840DCA000056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2013
• 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