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

Model Number 0800

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The account reported the bed was alarming and when it stopped alarming it started to smell of smoke and stopped functioning.The bed was located in (b)(6) at the facility and a patient was on the bed at the time of the allegation.The patient was removed from the bed and the bed was taken to the hill-rom service center for repair.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The technician investigated and found the bed alarm said low plenum pressure and the bed would not stay on.The technician checked the power supply and noticed the quick disconnect to the flower was burnt.The technician replaced the blower box assembly and the electrical box assembly to resolve the issue.Based on this information, no further action is required.

• Brand Name: CLINITRON RITEHITE BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 4121845
• MDR Text Key: 4938002
• Report Number: 1824206-2014-02035
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/03/2014

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: 07/03/2014
• Initial Date FDA Received: 07/28/2014
• 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