FDA Adverse Event
Death
Summary report: N
INTELLIVUE G5 AGM
MDR report key: 1729577
·
Received June 16, 2010
Report
- Report Number
- 9610816-2010-00202
- Event Type
- Death
- Date Received
- June 16, 2010
- Report Date
- June 14, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K060541
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE GAS MODULE PROVIDED INCORRECT (LOW) O2 MEASUREMENT DATA WHILE IN USE AND THAT A PT WENT INTO CARDIAC ARREST WHILE IN SURGERY. THE CUSTOMER ALSO STATED THAT THE ATTENDING ANESTHESIOLOGIST DID NOT CONSIDER THE DEVICE TO BE A CONTRIBUTING FACTOR IN THE INCIDENT. IN ABUNDANCE OF CAUTION, PHILIPS IS REPORTING THIS INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 REPORTED THAT THE GAS MODULE PROVIDED INCORRECT (LOW) O2 MEASUREMENT DATA WHILE IN USE AND THAT A PT WENT INTO CARDIAC ARREST WHILE IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE G5 AGM | MHX | PHILIPS MEDICAL SYSTEMS | M1019A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |