FDA Adverse Event
Malfunction
Summary report: N
MP30 INTELLIVUE PATIENT MONITOR
MDR report key: 1813388
·
Received August 20, 2010
Report
- Report Number
- 9610816-2010-00287
- Event Type
- Malfunction
- Date Received
- August 20, 2010
- Report Date
- July 23, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO ALARM DURING A DESAT EVENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 THE DEVICE FAILED TO ALARM DURING A DESAT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP30 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |