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

Model Number	P1170G
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that careassist power cord had damage with exposed copper wires.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
E1: (b)(6).The baxter technician found the power cord needed to be replaced.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.Examine the plug for damage.Make sure the plug is a one-piece molded plug assembly.If it is not, replace the plug cord assembly.Replace any plug cord assembly that shows any of these: discoloration of the plug molding around the plug blades; this could occur if the plug blades have overheated or arced.Any signs of cracking; this could occur if the plug has been bent and straightened to a point past its useful life.Loose fit of the plug blade (the plug blade moves in the molding); this could occur if the molding has overheated or the blades have been bent and straightened to a point past their useful life.Any signs of damage to the cable.Any exposed wires.Replace the power cord, if damaged.A search of baxter maintenance records showed baxter performed preventive maintenance on this bed in jul, 2026.It is unknown if the facility performed any other preventive maintenance on this bed.The technician replaced the power cord 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 NA 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50773970
• Report Number: 3006697241-2026-00342
• Device Sequence Number: 9424539
• Product Code: FNL
• UDI-Device Identifier: 00887761000278
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: P1170G
• Device Catalogue Number: P1170G0000190
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown