THERMAL ANALYZER
Received Aug 26, 2010 · Event occurred Dec 3, 2003
Report 2245578-2010-00053 · MDR key 1820951
Device
Product problems
- Overheating of Device
- Smoking
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS LATE MDR IS A RETROSPECTIVE FILING. ON (B)(6) 2003, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 1 ANALYZER WAS HOT TO TOUCH AND SMOKE WAS VISIBLE. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED.
Additional Manufacturer Narrative
THIS LATE MDR IS A RETROSPECTIVE FILING. THE RETROSPECTIVE FILING IS IN RESPONSE TO ABBOTT POINT OF CARE INC., (B)(4). FDA INSPECTION CONDUCTED JULY 2010. THE I-STAT PORTABLE CLINICAL ANALYZER AND THE I-STAT 1 ANALYZER OPERATE ON 9 VOLT BATTERIES. ACROSS THESE BATTERIES AND AT OTHER NODES CONNECTING TO THESE BATTERIES, A NUMBER OF TANTALUM CAPACITORS EXIST IN THE CIRCUITRY. SHOULD THE CAPACITORS EXPERIENCE A RELIABILITY FAILURE, A LOW INTERNAL IMPEDANCE PATH MAY FORM IN THE CAPACITOR RESULTING IN EXCESSIVE POWER DISSIPATION IN THE COMPONENT AS THE BATTERY IS EFFECTIVELY SHORT CIRCUITED. THERE ARE 4 OF THESE CAPACITORS IN EACH ANALYZER MODEL THAT CONNECT DIRECTLY TO THE BATTERIES. FOR THE I-STAT 1, THE REFERENCE DESIGNATORS FOR THE COMPONENTS ARE C4, C13, C26 AND C21. FOR THE I-STAT PORTABLE CLINICAL ANALYZER, THE REFERENCE DESIGNATORS ARE C169, C176, C180 AND C186. IN ADDITION, IT HAS BEEN DETERMINED DEFECTIVE BATTERY CARRIERS AND FLEX CABLES MAY ALSO CAUSE THE BATTERIES TO BE SHORT CIRCUITED. (B)(4).