MAUDE Adverse Event Report: HILL-ROM BATESVILLE HR 1000,VB100/200; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P1160B0000006
Medical Device Problem Codes	Intermittent Continuity (1121); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the caregiver controls needed to be replaced.Per the hillrom user manual: the hill-rom® 1000 bed requires an effective maintenance program.We recommend that you perform annual preventive maintenance (pm) and testing for joint commission.Pm and testing not only meet requirements but will help make sure a long, operative life for the hill-rom® 1000 bed.Pm will minimize downtime due to excessive wear.Perform annual preventive maintenance procedures to make sure all hill-rom® 1000 bed components are functioning as originally designed.Pay particular attention to safety features, including but not limited to the following: electrical system components; proper operation of the lockout controls.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the caregiver controls to resolve the issue.Based on this information, no further action is required.
Event or Problem Description
Hillrom received a report from the customer stating the head of the bed will run down on it's own and can not be raised back up.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: HR 1000,VB100/200
• 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: 11684837
• Report Number: 1824206-2021-00191
• Device Sequence Number: 3084936
• Product Code: FNL
• UDI-Device Identifier: 00887761000940
• UDI-Public: 010088776100094011160929
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: P1160B0000006
• 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: 03/22/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1