FDA Adverse Event
Death
Summary report: N
PHILIPS TC02 MODULE
MDR report key: 1736060
·
Received June 22, 2010
Report
- Report Number
- 9610816-2010-00213
- Event Type
- Death
- Date Received
- June 22, 2010
- Date of Event
- May 25, 2010
- Report Date
- June 15, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- KLK
- PMA / PMN Number
- K925910
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
THE CUSTOMER ALLEGED THAT THE TCGAS MODULE FAILED TO CALIBRATE PROPERLY AND FAILED TO PROVIDE ACCURATE MEASUREMENT DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS TC02 MODULE | KLK | PHILIPS MEDICAL SYSTEMS | M1018A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |