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

Model Number P1600B005348

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

The account found the bed exit siderail interface and the communication cable needed to be replaced.Per the hill-rom service manual the advanta bed requires an effective maintenance program.Preventative maintenance will minimize downtime due to excessive wear.Communications: inspect and test the communication junction box.Test the sidecom communication system features for proper operation.Inspect the communication cable including the male and female pins in the plug.Test the nurse call super capacitor for proper operation.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The account replaced the bed exit siderail interface and the communication cable to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom technical support received a report from the account stating the bed exit alarm was not alarming at the nurses' station.The bed was located in the med surg department 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: ADVANTA 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 8059635
• MDR Text Key: 127870766
• Report Number: 1824206-2018-00434
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1600B005348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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