CC NEXFIN WRIST UNIT
Received Mar 10, 2016 · Event occurred Jan 12, 2016
Report 2015691-2016-00743 · MDR key 5492430
Device
Generic name
Plethysmograph, Impedance
Manufacturer
Edwards Lifesciences BmeyeModel number
A1WU28Lot number
4932761
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS MANUFACTURED DECEMBER 09, 2010 AND REVIEW OF THE DEVICE HISTORY RECORD SUPPORTS THAT THERE WERE NO NON-CONFORMANCES NOTED DURING THE MANUFACTURING OF THE REFERENCED DEVICE. ADDITIONALLY, NO PRIOR SERVICE HAS BEEN DOCUMENTED FOR THIS DEVICE. THE ACTUAL VALUES, REPORTED AS ¿UNRELIABLE,¿ WERE REQUESTED; HOWEVER, THE INFORMATION WAS UNABLE TO BE ASCERTAINED. EXAMINATION OF THE RETURNED DEVICE FOUND NO FAULT WAS FOUND. NO PHYSICAL DAMAGE WAS FOUND IN THE VISUAL INSPECTION. IT IS UNKNOWN WHETHER PROCEDURAL PROCESSES OR A SPECIFIC CIRCUMSTANCE PLAYED A ROLE IN THE CUSTOMER'S EXPERIENCE, AS THE FAULT COULD NOT BE REPLICATED AND NO OTHER ISSUES WERE DETECTED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. IF ACTION IS REQUIRED AN APPROPRIATE INVESTIGATION WILL BE PERFORMED.
Additional Manufacturer Narrative
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP SUBMISSION WILL COMMUNICATE THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW, THE RETURNED PRODUCT EVALUATION RESULT(S), INVESTIGATION, AND CONCLUSION.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE, THE NEXFIN SINGLE CUFF WRIST UNIT PROVIDED 'UNRELIABLE MEASUREMENTS.' FURTHER DETAILS REGARDING THE VALUES OR MEANING OF 'UNRELIABLE MEASUREMENTS' WERE UNABLE TO BE OBTAINED. 'THE FINGER CUFF SOMETIMES INFLATED AND OCCASIONALLY DID NOT.' ADDITIONALLY, HALFWAY THROUGH A MEASUREMENT, IT OCCASIONALLY STOPPED WORKING. THERE WAS NO ALLEGATION OF PATIENT COMPROMISE AND NO ADDITIONAL SYSTEM-RELATED DEVICES WERE IDENTIFIED AS SUSPECT.