MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION P500 SURFACE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P005787R
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, baxter technician checked the power cord.The baxter technician thoroughly inspected the bed and was unable to duplicate the reported issue.The bed functioned as designed.However, if the reported event of a power cord exposing copper wires were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.
Event or Problem Description
A other health care professional contacted technical service to report that p500 mrs control unit had wires exposed on blower.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.

• Brand Name: P500 SURFACE
• 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: 25219216
• Report Number: 1824206-2026-01128
• Device Sequence Number: 9998055
• Product Code: FNL
• UDI-Device Identifier: 00887761001022
• UDI-Public: (01)00887761001022(11)110112
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/19/2026

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
• Device Model Number: P005787R
• Device Catalogue Number: P005787RENT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2011
• 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