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

Model Number	P7501A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the actuator needed to be replaced.It is necessary for the progressa bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Examine the pedals, cables, and cpr mechanism on the head motor.Make sure the screws are installed and fully tightened.Examine the condition of the two cpr release pedals, cpr cable and cpr mechanism on the head motor.Replace the head section motor in the event of a malfunction or the cpr cable if broken.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 technician replaced the actuator to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician stating the cpr function was inoperative.The bed was located at the account.There was no patient/user injury reported.

• Brand Name: PROGRESSA BED SYSTEM
• 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: 23426012
• Report Number: 1824206-2025-01905
• Device Sequence Number: 8392027
• Product Code: FNL
• UDI-Device Identifier: 00887761966925
• UDI-Public: (01)00887761966925(11)250228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/30/2025

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: P7501A
• Device Catalogue Number: P7501A000055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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