MAUDE Adverse Event Report: HILL-ROM BATESVILLE RESIDENT BED FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P870D000027
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the head and foot casters 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.Test each operating function individually to make sure that when pressed, the corresponding function operates correctly and when released, travel stops.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in jan 4, 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the head and foot casters.Based on this information, no further action is required.
Event or Problem Description
Hillrom received a report from the account stating the brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: RESIDENT BED FRAME
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12555730
• Report Number: 1824206-2021-00488
• Device Sequence Number: 4428274
• Product Code: FNL
• UDI-Device Identifier: 00887761000926
• UDI-Public: 010088776100092611170427
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: No Information
• Device Model Number: P870D000027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1