MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HILL-ROM RESIDENT LONG TERM CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P870D
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter submitted an estimate for the repair to insurance on behalf of the customer.The authorization for repair of this bed was not accepted by the customer.Account is seeking to replace the bed.Based on this information, no further action is required.Per the baxter service manual, it is necessary for the resident ltc bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Check the power cord, plug, and wiring for cuts, nicks, or breaks.Make sure that the wiring is routed where it is not pinched.Replace if necessary.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.Although there was no reported injury with this event, if the report of a damaged power cord with exposed wires were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that resident bed frame power cord was frayed with exposed copper wires.The bed was located at the account.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: HILL-ROM RESIDENT LONG TERM CARE 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: 22054079
• Report Number: 1824206-2025-00914
• Device Sequence Number: 17441450
• Product Code: FNL
• UDI-Device Identifier: 00887761000926
• UDI-Public: (01)00887761000926(11)140821
• 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): 05/20/2025

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: P870D
• Device Catalogue Number: P870D000028
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2014
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown