MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CAREASSIST BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P1170D
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-feb-2026, a company representative - service personnel contacted technical service to report that careassist es110/210/410, nul (product code p1170d0000006, serial number (b)(6)), had hi-low column raised on its own.This occurred after patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the motor control board needed to be replaced.Per the hillrom service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Hilow columns: inspect the column assembly for the presence and tightness of the attachment screws and the snap ring at the bottom of the column.Repair as necessary.Fully raise and lower the bed frame one time.Make sure there is no friction or abnormal noises and that no audible overload indication can be heard during the movement.Make sure the bed not down position indicator illuminates on the control pendant and goes out when the bed is in the low position.Replace the defective column(s) in the event of a malfunction.Troubleshoot in the event of a doubt.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in may 14, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the motor control board to resolve the reported event.Based on this information, no further action is required.

• Brand Name: CAREASSIST BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24550778
• Report Number: 3006697241-2026-00091
• Device Sequence Number: 5597382
• Product Code: FNL
• UDI-Device Identifier: 00887761000278
• UDI-Public: (01)00887761000278
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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): 03/09/2026

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: P1170D
• Device Catalogue Number: P1170D0000006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown