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

Model Number P7900B100009

Device Problems Intermittent Continuity (1121); Unintended Movement (3026)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the right pcb and caregiver controls were defective and 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.Make sure the brake is not set, and then plug the bed into an applicable power source.A steady alarm comes on.Set the brake.The alarm stops.Repair or replace as 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 right pcb and caregiver controls to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed would move into trend position when the bed was plugged into ac power.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: CENTRELLA MED-SURG
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 11893854
• MDR Text Key: 252929392
• Report Number: 1824206-2021-00270
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211200306
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P7900B100009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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