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

Model Number	P005787
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance pm and testing for joint commission certification.Pm and testing not only meet joint commission requirements but can help make sure of a long, operative life for the p500.Pm will minimize downtime due to excessive wear.Examine the plug for damage.Make sure the plug is a onepiece molded plug assembly.If it is not, replace the plug cord assembly.Replace any plug cord assembly that shows any of these: discoloration of the plug molding around the plug blades, this could occur if the plug blades have overheated or arced.Any signs of cracking, this could occur if the plug has been bent and straightened to a point past its useful life.Loos fit of the plug blade the plug blade moves in the molding, this could occur if the molding has overheated or the blades have been bent and straightened to a point past their useful life.Replace the power cord, if damaged.A search of the baxter maintenance records showed baxter performed preventive maintenance on this bed in feb 9,2024.It is unknown if the facility performed any other preventive maintenance on this bed.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician to report that power cord was exposing copper wires.The bed was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.This report was filed in our complaint handling system as complaint pr # (b)(4).

• 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 ; 2242702068
• MDR Report Key: 20403552
• Report Number: 1824206-2024-01430
• Device Sequence Number: 3351805
• Product Code: FNL
• UDI-Device Identifier: 00887761001022
• UDI-Public: (01)00887761001022(11)110106
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/08/2024

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: P005787
• Device Catalogue Number: P005787RENT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 06/01/2011
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown