MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COMPELLA BARIATRIC BED

Model Number	P7800A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the cpr handle needed to be replaced.Per the baxter 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: all caregiver and patient controls, along with their indicators, operate correctly; this includes controls for cpr.Replace or repair parts as necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in mar 26, 2026.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the cpr handle to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
A company representative - service personnel contacted technical service to report that compella rent us scale pd ppm had cpr handle not functioning properly.User defined description:warehouse repair.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.It was unknown if any second device was also involved.

• 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: 25274281
• Report Number: 1824206-2026-01199
• Device Sequence Number: 9703707
• Product Code: OSI
• UDI-Device Identifier: 00887761000902
• UDI-Public: (01)00887761000902(11)161020
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 04/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2016
• 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