TEMP MNGMT CONTROL UNIT
Received Apr 11, 2014
Report 1033422-2014-00009 · MDR key 3741804
Device
Generic name
Patient Warming System Model 1000 Control Unit
Manufacturer
Kimberly-clark Health CareModel number
01000-01RCatalog number
991099412
Lot number
4168
Product problems
- Melted
- Failure to Power Up
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿THE HOSPITAL OWNED UNIT HAS A MELTED FUSE. THIS WAS DISCOVERED PRIOR TO USE WHEN PLUGGING IN THE UNIT, THEY COULDN'T GET IT TO TURN ON. NOT USED ON ANY PATIENTS.¿ (B)(4).
Additional Manufacturer Narrative
THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.