MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, FLOTATION THERAPY, POWERED

Model Number P005787RENT02

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician has picked up the unit for evaluation and repair.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance.Control unit; make sure of these: the out of bed sensors operate correctly.Mattress assembly; make sure of these: the out of bed sensors and head of bed sensor mounting are not damaged.Repair or replace as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this unit in (b)(6) 2018.It is unknown if the facility performed any other preventative maintenance on this unit.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

Hill-rom received a report from the account stating the bed exit alarm was not working.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: P500 MRS CONTROL UNIT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 8200215
• MDR Text Key: 131743900
• Report Number: 1824206-2018-00497
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 11/30/2018

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: P005787RENT02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2010
• 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