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

Model Number P7900B200010

Device Problem Unintended Movement (3026)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the head section ran up unintentionally and the bed was showing an 0x9221 error.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 suggested the caregiver control 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.Do the function checks as applicable for your bed.If the bed passes all of the checks for its configuration, do the necessary administrative tasks, and prepare the bed to be put into service.If the bed does not pass all of the checks, repair or replace the part as applicable.Do not put the bed into service until it passes all of the checks.Warning¿report to bed authorized maintenance persons any unusual sounds, burning odors, or movement deviations observed in the controls, motors, or limit switch functions.Check the cable connection between the mcb and bcb.Replace or connect the cable as necessary.Replace the bcb.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.Hillrom technical support contacted the account three times trying to obtain the resolution for this event.No response has been received from the account.Based on this information, no further action is required.Suggested fix; requested update 3 times.

• 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 15894956
• MDR Text Key: 307886861
• Report Number: 1824206-2022-00515
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211211214
• 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: 12/01/2022

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: P7900B200010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2021
• 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