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

Model Number P870CB4823

Device Problem Sparking (2595)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the hilo drive control box assy 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 control lockout switch individually to make sure of proper operation.Check the power cord, plug, and wiring for cuts, nicks, or breaks.Make sure that the wiring is routed where it is not pinched.Replace if necessary.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 hilo drive control box assy to resolve the reported event.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed had no functions working and a spark could be seen where the beds motors are located.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
• 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: 15782439
• MDR Text Key: 307796203
• Report Number: 1824206-2022-00495
• Device Sequence Number: 1
• Product Code: FNL
• 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: 11/11/2022

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: P870CB4823
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2003
• 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