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

Model Number P3200K000500

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the head of the bed was moving on its own.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).

Manufacturer Narrative

The hillrom technician found the right and left foot control assy needed to be replaced.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Head section motor: examine the motor for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the head section.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Replace in the event of a malfunction.Make sure all functions on the caregiver control work correctly.Repair or replace the side rails as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the right and left¿foot control assy to resolve the reported event.Based on this information, no further action is required.

• Brand Name: VERSACARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15805830
• MDR Text Key: 303740951
• Report Number: 1824206-2022-00500
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000872
• UDI-Public: 010088776100087211180208
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Model Number: P3200K000500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1