PHILIPS TC02 MODULE
Received Jun 22, 2010 · Event occurred May 25, 2010
Report 9610816-2010-00213 · MDR key 1736060
Device
Manufacturer
Philips Medical SystemsModel number
M1018AProduct problems
- Incorrect Measurement
- Failure to Calibrate
Patient
Not reported
- Death
Narrative
Additional Manufacturer Narrative
THE CUSTOMER ALLEGED THAT THE TCGAS MODULE FAILED TO CALIBRATE PROPERLY AND FAILED TO PROVIDE ACCURATE MEASUREMENT DATA. THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS ANY DEVICE MALFUNCTION OR THAT THE USE OF THIS DEVICE WAS A FACTOR IN A DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem
THE CUSTOMER ALLEGED THAT THE TCGAS MODULE FAILED TO CALIBRATE PROPERLY AND FAILED TO PROVIDE ACCURATE MEASUREMENT DATA.