MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RESIDENT BED FRAME; LIFT PATIENT NON AC POWERED

Model Number	P870D000027
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted technical service to report that resident bed frame, had an issue, exposed wires on power cord.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The device was requested for service/inspection by baxter.
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.The resident ltc bed gives a unique combination of function, aesthetics, durability, and value to enhance the relationship between the patient and the long-term care facility.It offers a comfortable work height for caregivers and easy access for the patient.The technician replaced the control box with power cord to resolve the reported event.Based on this information, no further action is required.

• Brand Name: RESIDENT BED FRAME
• Common Device Name: LIFT PATIENT NON AC POWERED
• 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: 20604147
• Report Number: 1824206-2024-01552
• Device Sequence Number: 12798090
• Product Code: FSA
• UDI-Device Identifier: 00887761000926
• UDI-Public: (01)00887761000926
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: P870D000027
• Device Catalogue Number: P870D000027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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