MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CENTRELLA SURFACE; BED, FLOTATION THERAPY, POWERED

Model Number	P7922A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician to report the centrella max mattress, wide siderail false latches; when applying weight to the siderail makes it come down.The bed was located at the account.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.
Additional Manufacturer Narrative
The baxter technician found the bed needed to be swapped.Per the baxter service manual, it is necessary for the centrella bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Do the function checks as applicable for your bed.If the bed passes all of the checks for its configuration, do the necessary administrative tasks, and prepare the bed to be put into service.If the bed does not pass all of the checks, repair or replace the part as applicable.Do not put the bed into service until it passes all of the checks.Warning¿report to bed authorized maintenance persons any unusual sounds, burning odors, or movement deviations observed in the controls, motors, or limit switch functions.Check the cable connection between the mcb and bcb.Replace or connect the cable as necessary.Replace the bcb.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 bed was swapped to resolve the reported event.Based on this information, no further action is required.If any further information is received, the complaint will be reassessed as applicable.

• Brand Name: CENTRELLA SURFACE
• 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: 21265773
• Report Number: 3006697241-2025-00014
• Device Sequence Number: 4252056
• Product Code: IOQ
• UDI-Device Identifier: 00887761976979
• UDI-Public: (01)00887761976979(11)240808
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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
• Device Model Number: P7922A
• Device Catalogue Number: P7922ARENT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown