MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Compella Surface; Bariatric bed

Model Number	P7800A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that the compella cap us scale pd ppm failed to stop.This occurred during baxter servicing/testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the power drive needed to be replaced.Per the hillrom service manual the compella bed requires an effective maintenance program.We recommend that you perform annual preventative maintenance.Pay particular attention to safety features, which include but are not limited to: controls return to off or the neutral position when released.Make sure that the controls are in good condition and that the membranes are not worn or torn.Do the function checks.Make sure that the bed does not fail any of the function checks.Replace or repair parts as necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in aug 2025.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the intellidrive transport handles to resolve the reported event.Based on this information, no further action is required.

• Brand Name: Compella Surface
• Common Device Name: Bariatric bed
• 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 ; +1(224)270-5355
• MDR Report Key: 50820620
• Report Number: 1824206-2026-02250
• Device Sequence Number: 18803578
• Product Code: OSI
• UDI-Device Identifier: 00887761000902
• UDI-Public: (01)00887761000902(11)181024
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: P7800A
• Device Catalogue Number: P7800A000001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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
• Patient Sex: Unknown