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

Model Number P7900B000022

Device Problem No Audible Alarm (1019)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hillrom received a report from a hillrom technician stating the bed had no bed exit alarm.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).

Event Description

Hillrom received a report from a hillrom technician stating the bed had no bed exit alarm.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 both fuds 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 preventative maintenance (pm).Make sure the bed exit system operates correctly.Replace parts if necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on january 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced both fuds to resolve the reported event.Based on this information, no further action is required.

• 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: 16055324
• MDR Text Key: 308453462
• Report Number: 1824206-2022-00543
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211190102
• 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,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7900B000022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2019
• 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