MAUDE Adverse Event Report: HILL-ROM INC. P500; BED FLOTATION THERAPY POWERED

Model Number 0057

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the cpr function is not working.The unit is located in the icu at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the cpr switch is defective.Per the hill-rom service manual, the p500 mattress requires an effective maintenance program.Preventative maintenance will minimize downtime due to excessive wear.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.The technician replaced the cpr switch to resolve the issue.Based on this info, no further action is required.

• Brand Name: P500
• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4691750
• MDR Text Key: 5676231
• Report Number: 1824206-2015-00490
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/16/2015

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: 0057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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