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

Model Number	P1600B
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that advanta frame had cpr function not working.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the cpr linkage needed to be replaced.Per the baxter 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.Examine the handles, cables, and cpr mechanism on the head motor.Make sure the screws are installed and fully tightened.Raise the head section to the high position, then activate one of the cpr releases.Make sure the head section lowers.Adjust the cpr cable as necessary.Do the same test on the other side of the bed.Release the cpr handles and make sure the mechanism locks correctly by operating the head up control for a few seconds.The head section should rise.Replace the head section motor as necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in nov 24, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the cpr linkage to resolve the reported event.Based on this information, no further action is required.

• 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 BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25480595
• Report Number: 1824206-2026-01336
• Device Sequence Number: 21314785
• Product Code: FNL
• UDI-Device Identifier: 00887761000933
• UDI-Public: (01)00887761000933(11)020110
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/11/2026

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: P1600B
• Device Catalogue Number: P1600B004188
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2002
• 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