MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION P500 MRS CONTROL UNIT; BED, FLOTATION THERAPY, POWERED

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	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the baxter technician found the power cord needed to be replaced.The p500 surface is for household and healthcare facility use.The p500 surface is a finished size of 35.5" (90 cm) wide by 84" (213 cm) long, with a thickness of 8" (20 cm).The surface is designed for use on pan-deck frames that accommodate this surface size; it is not intended for use on spring-deck frames.The intended users of this product are healthcare employees, non-clinical caregivers, and occupants who have the physical strength and cognitive skills to operate and control the product.Follow safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely.A search of the baxter maintenance records showed baxter performed any preventative maintenance on this bed on 18th jun 2024.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.
Event or Problem Description
A company representative - service personnel contacted technical service to report that p500 mrs control unit power cord is frayed with exposed wires.User defined description:warehouse repair.This occurred after patient 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 MRS CONTROL UNIT
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• 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: 20911444
• Report Number: 1824206-2024-01863
• Device Sequence Number: 18098900
• Product Code: IOQ
• UDI-Device Identifier: 00887761001022
• UDI-Public: (01)00887761001022(11)170417
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: P005787
• Device Catalogue Number: P005787RENT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/12/2024
• 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