VP 2000 PROCESSOR
Received Mar 25, 2016 · Event occurred Mar 2, 2016
Report 3005248192-2016-00001 · MDR key 5526929
Device
Product problems
- Temperature Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ELEVATED COMPLAINT INVESTIGATION (B)(4) FOR MDR 3005248192-2016-00001 FOLLOW-UP REPORT 1 INCLUDED AN EXISTING DATA REVIEW, QUALITY DATA REVIEW (CAPA/NONCONFORMANCE REVIEW), PRODUCT/SYSTEM/INSTRUMENT EVALUATION, AND COMPLAINT HISTORY REVIEW. THE INFORMATION IN THIS COMPLAINT IDENTIFIED THAT DRYER ASSEMBLY (PART 30-144163RO) FAILURES DID OCCUR HOWEVER THE OVERALL PRODUCT DESIGN REQUIREMENTS CONTINUE TO BE MET. THE OVERALL PRODUCT PERFORMED AS DESIGNED, PER SAFETY STANDARD IEC 61010-1, AND CONTINUES TO PERFORM AS EXPECTED WHEN THIS FAILURE MODE OCCURS, AS THERE IS NO EVIDENCE THAT THE SINGLE FAULT CONDITION TEMPERATURE EXCEEDED 105°C ON ANY TOUCHABLE SURFACE. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED AFTER AN ELEVATED COMPLAINT INVESTIGATION CONCLUDES.
Description of Event or Problem
THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. CUSTOMER REPORTED THAT THE RACK HOLDING THE SLIDES WAS UNEXPECTEDLY WARM TO THE TOUCH. IT WAS REPORTED THAT THE RACK WITH THE SLIDES WAS ALMOST DROPPED DUE TO THE TEMPERATURE. THERE WAS NO REPORT OF INJURY. THE ABBOTT FIELD SERVICE ENGINEER (FSE) REPLACED THE AIR DRYER ASSEMBLY AND VERIFIED THE AIR DRYER ASSEMBLY TEMPERATURE. ALL TEMPERATURES AND CHECKS WERE WITHIN MANUFACTURER SPECIFICATIONS. THE FSE RESTORED THE VP2000 TO ITS OPERATIONAL CONDITION. AN ABBOTT ELEVATED COMPLAINT INVESTIGATION HAS BEEN INITIATED.