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

Model Number P7900B100011

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the master control power control board, head actuator and foot actuator 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.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Hilow motor: examine the motor for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the bed.If the bed does not fully raise and lower, calibrate the bed position sensor.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Make sure the bed not down led lights up on the control pendant and goes out when the bed is in low position.Replace the defective motor(s) in the event of a malfunction.Troubleshoot in the event of a doubt.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 master control power control board, head actuator and foot actuator 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's head high/low and frame high/low were engaging without pressing any buttons on the bed's control panel (self run).The bed was located in the bed shop 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 master control power control board, head actuator and foot actuator needed to be replaced.Per the hillrom service manual, it is necessary for the centrella¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Plug the bed into a power outlet.Make sure all functions on the caregiver control panel operate correctly.Repair or replace the siderail 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 master control power control board, head actuator and foot actuator 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's head high/low and frame high/low were engaging without pressing any buttons on the bed's control panel (self run).The bed was located in the bed shop 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 10045749
• MDR Text Key: 193629828
• Report Number: 1824206-2020-00207
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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 Operator: No Information
• Device Model Number: P7900B100011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• 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