FDA Adverse Event
Malfunction
Summary report: N
MP20 INTELLIVUE PATIENT MONITOR
MDR report key: 1812659
·
Received August 13, 2010
Report
- Report Number
- 9610816-2010-00317
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Report Date
- July 9, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM. NO ADVERSE IMPACT HAS BEEN REPORTED. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THERE WAS ANY 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP20 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8001A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |