MAUDE Adverse Event Report: CLINITRON RITE-HITE; BED

Device Problems Device Alarm System (1012); Smoking (1585)

Patient Problem No Information (3190)

Event Date 12/29/2015

Event Type  Injury  

Event Description

The pt activated the call light system to notify staff that his bed was hard.The bed was not alarming, there were no lights on the bed.Staff took the bed plug out of the wall and attempted a red outlet with no change.The staff then heard a popping sound and smoke starting coming from the bed.Staff immediately moved the pt to a new bed.

• Brand Name: RITE-HITE
• Type of Device: BED
• Manufacturer (Section D): CLINITRON; chicago IL 60601
• MDR Report Key: 5366142
• MDR Text Key: 36042698
• Report Number: MW5059303
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2016

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR