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

Model Number	P7900A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the actual device could not be returned; however, a baxter technician performed an on-site evaluation of the device.The patient positioning mattress (ppm) tested and performed according to product specifications.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.The investigation is currently ongoing, a final report will be submitted upon completion.
Event or Problem Description
It was reported a patient fell from a centrella bed and sustained an injury.The patient was put onto the bed.The medical staff ¿zeroed the bed;¿ however, the bed alerted the staff that the ¿¿patient weight too low-unable to set bed alarm¿.The patient weighed 68lbs, and per the instructions for use state the bed ¿is intended for patient populations weighing at least 70lbs (32 kg) and is capable of supporting patients up to 500lbs (227 kg).¿ the bed exit alarm could not be set, and subsequently the patient fell from the bed and sustained a hip fracture.The patient required unspecified treatment at the hospital.Additionally, no bed malfunction was reported.No further information was available at the time of this report.

• Brand Name: CENTRELLA BED
• 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: 24071513
• Report Number: 1824206-2026-00105
• Device Sequence Number: 9350656
• Product Code: FNL
• UDI-Device Identifier: 00887761999961
• UDI-Public: (01)00887761999961(11)180626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: Health Professional
• Device Model Number: P7900A
• Device Catalogue Number: P7900A000019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown