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

Model Number P1600B

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative performed troubleshooting over the phone with the account, asking the account to isolate the side rails.Per the hill-rom service manual the advanta bed requires an effective maintenance program.Preventative maintenance will minimize downtime due to excessive wear.Run the bed to the full upper and lower limits to ensure proper function of both head and foot hilow drive limit switches.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 right caregiver switch assembly to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed would run down after being plugged into ac power.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).

• Brand Name: ADVANTA BED GENERIC
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8186607
• MDR Text Key: 131499395
• Report Number: 1824206-2018-00489
• 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
• Report Date: 12/07/2018

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: Other
• Device Model Number: P1600B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1