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	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that resident bed frame patient right side siderail was not latching in place.The bed was located at the account.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Baxter technician determined that the spring and shoulder screw needed to be replaced.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.Inspect for proper up, down, and storage operation for the siderail, as well as the locking latch for proper operation.Lubricate the mechanism.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.Baxter technical support provided the account the part numbers of the siderail mechanism that needs to be replaced to resolve the issue and contacted the account two additional 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.

• 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: 20539115
• Report Number: 1824206-2024-01503
• Device Sequence Number: 6697343
• Product Code: FNL
• UDI-Device Identifier: 00887761000926
• UDI-Public: (01)00887761000926(11)110218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: P870D000001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2011
• 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: N/A.
• Patient Sex: Unknown