MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COMPELLA BARIATRIC BED

Model Number	P7800A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test on the siderails.The baxter technician thoroughly inspected the bed and was unable to duplicate the reported issue.The bed functioned as designed.However, if the reported event of siderail latch but gives out if force is used were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.
Event or Problem Description
A other health care professional contacted technical service to report that compella rent us scale pd ppm siderail was false latching.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.

• Brand Name: COMPELLA BARIATRIC BED
• 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 ; 2242705355
• MDR Report Key: 25408790
• Report Number: 1824206-2026-01291
• Device Sequence Number: 13429133
• Product Code: OSI
• UDI-Device Identifier: 00887761000902
• UDI-Public: (01)00887761000902(11)161027
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/05/2026

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
• Device Model Number: P7800A
• Device Catalogue Number: P7800ARENT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2016
• 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