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 Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician to report that resident bed frame ac power cable was broke with exposed copper wires.The bed was located at the account.There was no patient/user injury, medical intervention, symptom, or adverse event reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
The baxter technician found the ac power cord needed to be replaced.Per the hillrom service manual, it is necessary for the resident ltc bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Make sure the power cord is not damaged and it is connected to the bed.Replace the power cord as necessary.Check the ac inlet to psm cable assembly for kinks, damage, and connections.Replace or connect the cable as necessary.Replace parts as 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.The technician replaced the ac power cord to resolve the reported event.Based on this information, no further action is required.

• 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: 20361748
• Report Number: 1824206-2024-01419
• Device Sequence Number: 8004345
• Product Code: FNL
• UDI-Device Identifier: 00887761000926
• UDI-Public: (01)00887761000926(11)080501
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: P870D000027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2008
• 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