FDA Adverse Event
Death
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 3052568
·
Received April 4, 2013
Report
- Report Number
- 9610816-2013-00077
- Event Type
- Death
- Date Received
- April 4, 2013
- Date of Event
- March 23, 2013
- Report Date
- March 27, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PT WHO WAS ATTACHED TO AN INTELLIVUE MONITORING SYSTEM (MP70 AND PIIC) WAS FOUND EXPIRED. 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PT WHO WAS ATTACHED TO AN INTELLIVUE MONITORING SYSTEM (MP70 AND PIIC) WAS FOUND EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139560 | MP70 INTELLIVUE PATIENT MONITOR | DSI | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |