MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P005723CAP02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The service technician found the power cord had damaged exposing copper.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
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 one-piece 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.¿ loose 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 did not show baxter performed any preventative maintenance on this bed.¿ it is unknown if the facility performs preventative maintenance on their beds.¿¿ the technician replaced the power cord to resolve the reported event.¿¿based on this information, no further action is required.

• Brand Name: P500 MRS CONTROL UNIT
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 19476417
• Report Number: 1824206-2024-00754
• Device Sequence Number: 6913378
• Product Code: FNL
• UDI-Device Identifier: 00887761001015
• UDI-Public: 010088776100101511210123
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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
• Device Model Number: P005723CAP02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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