MAUDE Adverse Event Report: HILL-ROM CLILNITRON RITE HITE; CLINITRON RITE HITE

Model Number 9007

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Nurse mgr completing rounds when she noted a smell from the hallway consistent with burning.Nurse entered pt room to find clinitron bed to smell as though it was burning and then noted a small amount of smoke coming from the bottom/underneath of the bed.Pt immediately removed from the bed and placed on a foam mattress.Hill-rom was contacted to come remove the bed and deliver a new one.New bed delivered.Pt remained unaffected by bed malfunction.

• Brand Name: CLILNITRON RITE HITE
• Type of Device: CLINITRON RITE HITE
• Manufacturer (Section D): HILL-ROM; batesville IN 47006
• MDR Report Key: 3701912
• MDR Text Key: 4234046
• Report Number: MW5035202
• 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
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9007
• Device Catalogue Number: P0800010019
• Other Device ID Number: 12074729
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR