FDA Adverse Event
Death
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 1655770
·
Received April 7, 2010
Report
- Report Number
- 9610816-2010-00094
- Event Type
- Death
- Date Received
- April 7, 2010
- Date of Event
- March 31, 2010
- Report Date
- April 1, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT A PATIENT SATURATION LEVEL WENT DOWN, BUT THE ALARM WAS NOT HEARD. THE PATIENT WAS FOUND DEAD. ALARM LOGS AND STRIPS WILL BE RETRIEVED BY THE FIELD. THE CUSTOMER TESTED THE INVOLVED DEVICE AND IT WAS FULLY FUNCTIONAL FOR ALARMING FOR DESATURATION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 A PATIENT SATURATION LEVEL WENT DOWN, BUT THE ALARM WAS NOT HEARD AND THE PATIENT WAS FOUND DEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP70 INTELLIVUE PATIENT MONITOR | DSI | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |