FDA Adverse Event
Death
Summary report: N
INFORMATION CENTER NETWORK DATABASE
MDR report key: 1668782
·
Received April 22, 2010
Report
- Report Number
- 1218950-2010-00547
- Event Type
- Death
- Date Received
- April 22, 2010
- Date of Event
- April 15, 2010
- Report Date
- April 21, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K01109
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT NO RED ALARMS WERE HEARD FROM 2-3PM AND THE PATIENT EXPIRED AT APPROX 3PM. ALARM LOG FOR THE INVOLVED CENTRAL STATION SHOW ONLY RED ALARMS AND DO SHOW AN ASYSTOLE ALARM AT 3:02PM. THIS DATA SUPPORTS THAT THERE WAS NO MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT, 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 NO RED ALARMS WERE HEARD AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFORMATION CENTER NETWORK DATABASE | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3155B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |