MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADVANTA 2 BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P1190A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the left siderail cable and controls needed to be replaced.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.Per the hillrom service manual the advanta 2 should be subject to an effective maintenance program.This will help make sure of a long, operative life for the advanta 2 bed.The preventative maintenance will help to reduce downtime due to excessive wear failures.An annual service of the bed is advised in order to maintain its characteristics and performance.Make sure the head and foot siderails are not bent or twisted.Make sure the latch mechanism operates correctly.An audible click must be heard.Remove the siderail cover, and make sure the mounting screws are tight.Inspect the cable routing for pinching, binding, and damage.Make sure all functions on the caregiver control operate correctly.Repair or replace the siderail as necessary.The technician replaced the left siderail cable and controls to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report that advanta 2 frame had bed head section raises on it's own.This occurred after patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: ADVANTA 2 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: 25368782
• Report Number: 3006697241-2026-00209
• Device Sequence Number: 21197940
• Product Code: FNL
• UDI-Device Identifier: 00887761000933
• UDI-Public: (01)00887761000933(11)150809
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/02/2026

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: P1190A
• Device Catalogue Number: P1190A000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2015
• 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