MAUDE Adverse Event Report: HILL ROM HILL ROM; CLINITRON SAND/AIR BED

Model Number CR 300878

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Event Description

Nurse entered room, smelled smoke, noticed haze in room.Pt removed from bed, bed removed from service.No harm to pt.

• Brand Name: HILL ROM
• Type of Device: CLINITRON SAND/AIR BED
• Manufacturer (Section D): HILL ROM ; two prudential plaza; suite 4100 n; chicago IL
• MDR Report Key: 5187525
• MDR Text Key: 29930815
• Report Number: MW5057525
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CR 300878
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 72