MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TOTALCARE SPORT PLUSSURFACE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	TCSPORT
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the cpr valve was faulty.The totalcare bed system is intended to provide a patient support ideally suited to be used in health care environments.The totalcare bed system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The totalcare bed system is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The intended users of this product are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product.Per the baxter service manual the totalcare bariatric bed and totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Test the cpr release for correct operation and reset of the head cylinder.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in (b)(6) 2024.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the cpr valve to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
It was reported that total care sport (product code tcsport, serial number (b)(6), cpr function was not able to be activated.The bed was located at the account and occurred during baxter servicing/testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: TOTALCARE SPORT PLUSSURFACE
• 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: 21180709
• Report Number: 1824206-2025-00065
• Device Sequence Number: 4287007
• Product Code: FNL
• UDI-Device Identifier: 00887761999596
• UDI-Public: (01)00887761999596(11)081006
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/17/2025

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: TCSPORT
• Device Catalogue Number: TCSPORT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2008
• 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