MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HILL-ROM1000 BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P1160B
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the right caregiver control 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.Pay particular attention to safety features, including but not limited to the following: electrical system components; proper operation of the lockout controls.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 right caregiver control.Baxter contacted the account three times trying to obtain the resolution for this event.No response has been received from the account.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician to report the hr1000 ran up unintentionally.The device was located at the account.This occurred during biomed testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.

• Brand Name: HILL-ROM1000 BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21638622
• Report Number: 3006697241-2025-00067
• Device Sequence Number: 8510957
• Product Code: FNL
• UDI-Device Identifier: 00887761000940
• UDI-Public: (01)00887761000940(11)171003
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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: P1160B
• Device Catalogue Number: P1160B0000004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2017
• 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