FLOTEC
Received Feb 12, 2019 · Event occurred Jun 6, 2009
Report 1832475-2019-00001 · MDR key 8333247
Device
Generic name
Ingage Regulator
Manufacturer
Flotec Inc.Product problems
- Detachment of Device or Device Component
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.
Description of Event or Problem
THIS REPORT IS OUR RESPONSE TO REPORT NUMBER MW5012641 WITH MDR REPORT KEY (B)(4). THAT REPORT WAS ISSUED ON 08/27/2009. DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.