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	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the cpr handles needed to be replaced.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in mar 31, 2026.It is unknown if the facility performed any other preventative maintenance on this bed.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.The technician replaced the cpr handles to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report that careassist es155/255/455 had cpr function not activating.N issue.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: 25555915
• Report Number: 3006697241-2026-00224
• Device Sequence Number: 9996165
• Product Code: FNL
• UDI-Device Identifier: 00887761000278
• UDI-Public: (01)00887761000278(11)130219
• 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): 06/18/2026

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: 05/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown