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	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that tc bariatric plus w/ air the head of the bed will not rise up.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 head section.Per the baxter service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the head section slide pivots, self-lubricating bearing, and slider pivot extrusions.Look for damage and make sure the head section operates correctly.Replace components as necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in (b)(6) 2026.It is unknown if the facility performed any other preventative maintenance on this bed.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 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: 25119065
• Report Number: 1824206-2026-01011
• Device Sequence Number: 10289507
• Product Code: IOQ
• UDI-Device Identifier: 00887761000865
• UDI-Public: (01)00887761000865(11)141130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/07/2026

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2014
• 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