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

Model Number	P3255A
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that pro+ versacare had power cord burnt.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technical support representative performed troubleshooting over the phone with the account, asking the account to replace the power cord.Per the baxter service manual, perform annual preventive maintenance procedures to make sure all versacare bed components are functioning as originally designed.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.Any signs of cracking., loose fit of the plug blade (the plug blade moves in the molding), verify that the strain relief p-clip is present.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 account replaced the power cord no further action needed.

• 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, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25311530
• Report Number: 3006697241-2026-00201
• Device Sequence Number: 5418126
• Product Code: IOQ
• UDI-Device Identifier: 00887761007543
• UDI-Public: (01)00887761007543(11)251120
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/27/2026

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
• Operator of Device: Other
• Device Model Number: P3255A
• Device Catalogue Number: P3255A08
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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