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

Model Number	P7501A
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 14-jan-2026, a other health care professional contacted technical service to report that progressa plus (product code p7501a000032, serial number (b)(6)), had bed exit not sending signal to nurse call.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test on the head section.It is necessary for the progressa bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Examine and test the communication junction box.Make sure the sidecom communication system feature works correctly.Examine the communication cable, include the male and female pins in the plug.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 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 bed exit not alarming at the nurse's station were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.

• Brand Name: PROGRESSA BED
• 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 ; 2242705355
• MDR Report Key: 24314597
• Report Number: 1824206-2026-00315
• Device Sequence Number: 5676725
• Product Code: FNL
• UDI-Device Identifier: 00887761966925
• UDI-Public: (01)00887761966925(11)230516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2026

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: P7501A
• Device Catalogue Number: P7501A000032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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