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

Model Number	P1190A
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the left care giver controls needed to be replaced.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in feb 13, 2026.It is unknown if the facility performed any other preventative maintenance on this bed.Per the baxter service manual the advanta 2 should be subject to an effective maintenance program.Test each of the buttons to check that they activate the correct function and that they do not work intermittently by pressing each button for several seconds.Each movement must be continuous.Replace the pendant if necessary.The technician replaced the left care giver controls to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report that advanta2 rental bed had head of the bed will go down on its own.This occurred during 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: 25728028
• Report Number: 3006697241-2026-00243
• Device Sequence Number: 10484174
• Product Code: FNL
• UDI-Device Identifier: 00887761000933
• UDI-Public: (01)00887761000933(11)170109
• 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): 07/06/2026

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: P1190ARENT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2017
• 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