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

Model Number P7900A000011

Device Problem Activation Problem (4042)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed cpr was inoperative.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 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.Make sure the cpr feature operates 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 actuator to resolve the reported event.Based on this information, no further action is required.

• Brand Name: CENTRELLA 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: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17652035
• MDR Text Key: 322305521
• Report Number: 1824206-2023-00998
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761999961
• UDI-Public: 010088776199996111180118
• 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: 08/30/2023

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: P7900A000011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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