MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON RITEHITE; BED, AIR FLUIDIZED

Model Number 0800

Device Problems Smoking (1585); Device Inoperable (1663)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

The technician swapped the bed and found at the hill-rom service center the bed was smoking around the power cord and electrical box caught fire due to unknown reasons.Per the hill-rom user manual, warning: if an electrical or mechanical problem occurs, the call for service light illuminates on the control panel, and an alarm sounds for the first 10 minutes.If this occurs, contact the hill-rom help line at 800-638-2546 immediately.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 technician replaced the electrical box 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 smoked and had no functions.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: CLINITRON RITEHITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5195005
• MDR Text Key: 30280363
• Report Number: 1824206-2015-01004
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2015

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: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/02/2015
• 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