MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRO+; BED, FLOTATION THERAPY, POWERED

Model Number	P3255A02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.It is necessary for the pro+ mattress to have an effective maintenance program.We recommend that you do annual preventive maintenance (pm) and testing for joint commission certification.Examine the entire length of the mattress power cord.Make sure there are no cuts or exposed wires.Make sure the plug is a one-piece molded plug assembly.Examine the plug for damage.Replace the mattress power cord if the plug shows: discoloration of the plug molding on or around the plug blades.Signs of cracking.Loose fit of the plug blade (the plug blade moves in the molding).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.
Event or Problem Description
It was reported that pro+ versacare mrs w/o x-ray (product code p3255a02, serial number (b)(6)), had power cord damage with exposed copper wires.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: PRO+
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22038219
• Report Number: 3006697241-2025-00155
• Device Sequence Number: 8177880
• Product Code: IOQ
• UDI-Device Identifier: 00887761977853
• UDI-Public: (01)00887761977853(11)241205
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 05/16/2025

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: P3255A02
• Device Catalogue Number: P3255A02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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