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

Model Number	P7924ARENT01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/23/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The exact causality of the patient's deep tissue pressure injury and decease is undetermined; this event is possibly due to the patient's declined status on admission as noted by the customer, additionally, it was reported the patient was unable to get out of bed and that a turn schedule was implemented after development of the dti.The actual device could not be returned; however, a baxter technician performed an on-site evaluation of the device.During functional testing the device passed all necessary testing.The event history log review showed no evidence of the customer reported problem.The device was found to be performing per product specifications.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was no air running through the pro+ and the patients¿ pressure wounds were getting worse.The customer reported the location of the pressure sores were along his spine from his mid-upper back down to his coccyx and stated they were unstageable deep tissue.The customer was unable to provide the staging of the pressure wounds prior to them getting worse.The customer reported that a turn schedule was implemented and then they started to use a dressing, customer did not remember the name but stated "it was like aquacel." the patient was transferred to a higher level of care, after this the patient passed away (date unknown).The customer noted on admission the patient was "extremely declined and was unable to get out of bed".It is unknown when the patient died or the cause of death.It was not reported if an autopsy was performed.A baxter technician inspected the bed and was unable to duplicate any issues.The technician found the bed to be functioning as designed.No further information was available at the time of this report.

• 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: 25232663
• Report Number: 3006697241-2026-00192
• Device Sequence Number: 10183550
• Product Code: IOQ
• UDI-Device Identifier: 00887761976863
• UDI-Public: (01)00887761976863(11)211102
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: P7924ARENT01
• Device Catalogue Number: P7924ARENT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown