GIVEN IMAGING
Received Jan 11, 2012 · Event occurred Dec 21, 2011
Report MW5023806 · MDR key 2419187
Device
Product problems
- Calibration Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
MALFUNCTION OF PH MONITORING DEVICE MADE BY GIVEN IMAGING. AFTER CALIBRATION OF CAPSULE AND ATTACHMENT WITHIN THE ESOPHAGUS THE EXTERNAL RECEIVER MALFUNCTIONED STATING CALIBRATE CAPSULE. CAPSULE COULD NOT BE RECALIBRATED DUE TO ATTACHMENT WITHIN THE ESOPHAGUS. CAPSULE WAS REMOVED. A DIFFERENT RECEIVER A CAPSULE WERE CALIBRATED AND THE NEW CAPSULE WAS ATTACHED WITHOUT INCIDENT. NO NEGATIVE OUTCOME WITH PT. THE MAKER OF THE PRODUCT, GIVEN IMAGING WAS NOTIFIED. THEY WERE UNABLE TO ASSIST WITH QUALITY ASSURANCE DIAGNOSIS OF THE RECEIVER SINCE THE PRODUCT WAS OUT OF WARRANTY. THEIR ONLY SOLUTION WAS TO BUY ANOTHER RECEIVER FROM THEM. THEY STATED THAT THEY DO NOT SERVICE PRODUCTS THAT ARE OUT OF WARRANTY IN ANYWAY. DATES OF USE: 2 YEARS.