MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HILL-ROM 100 LOW BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P3930A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.Per the hillrom user manual: the hill-rom 1000 bed requires an effective maintenance program.We recommend that you perform annual preventive maintenance (pm) and testing for joint commission.Pm and testing not only meet requirements but will help make sure a long, operative life for the hill-rom 1000 bed.Pm will minimize downtime due to excessive wear.Perform annual preventive maintenance procedures to make sure all hill-rom 1000 bed components are functioning as originally designed.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 power cord to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
On 13-nov-2025, a customer contacted technical service to report that gpac frame-assembled (product code p3930a000026, serial number (b)(6) , had power cord damaged with copper wires exposed.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: HILL-ROM 100 LOW 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 ; 2242702068
• MDR Report Key: 23717153
• Report Number: 1824206-2025-02222
• Device Sequence Number: 10298318
• Product Code: FNL
• UDI-Device Identifier: 00887761000919
• UDI-Public: (01)00887761000919(11)990819
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/04/2025

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
• Operator of Device: Other
• Device Model Number: P3930A
• Device Catalogue Number: P3930A000026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/1999
• 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