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

Model Number	P1170G
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the cpr cabling needed to be replaced and adjusted.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 handles, brackets, and cables.Make sure that they are in good condition and secured to the bed.Make sure that the bracket and assembly are not bent or damaged.Make sure that the cable is not corroded.Replace or repair parts as necessary.Make sure that the screws are installed and fully tightened.Replace or tighten the screws as necessary.Fully raise the head section, then activate one of the cpr releases.Make sure that the head section lowers.Adjust the cpr cable as necessary.Do the same test on the other side of the bed.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.The technician replaced and adjusted the cpr cable to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
On (b)(6) 2026, a company representative - service personnel contacted technical service to report that care assist es155/255/455 (product code p1170g0000069, serial number (b)(6), had cpr feature unable to be activated.This occurred after patient use.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: 24421713
• Report Number: 3006697241-2026-00071
• Device Sequence Number: 18793659
• Product Code: FNL
• UDI-Device Identifier: 00887761000278
• UDI-Public: (01)00887761000278(11)130225
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2026

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: P1170G0000069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2013
• 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