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

Model Number	P1170B
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter technical support provided the account the part number of the external alarm that needs to be replaced to resolve the issue.The account will repair the bed themselves.Based on this information, no further action is required.Per the baxter 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.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Check the brakes to see whether the bed moves when the brake pedals are pressed and repair as necessary.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental.
Event or Problem Description
On 13-feb-2026, a other health care professional contacted technical service to report that care assist ca100 (product code p1170b0000020, serial number (b)(6)), had brakes not holding.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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: 24598069
• Report Number: 3006697241-2026-00098
• Device Sequence Number: 15542362
• Product Code: FNL
• UDI-Device Identifier: 00887761000278
• UDI-Public: (01)00887761000278
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: P1170B
• Device Catalogue Number: P1170B0000020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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