FDA Adverse Event
Malfunction
Summary report: N
MP30 INTELLIVUE PATIENT MONITOR
MDR report key: 2281080
·
Received September 15, 2011
Report
- Report Number
- 9610816-2011-00543
- Event Type
- Malfunction
- Date Received
- September 15, 2011
- Report Date
- September 9, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE REPORTED DESCRIPTION NOTES THAT A SPEAKER MALFUNCTION MESSAGE WAS DISPLAYED. IT IS UNK IF THE SPEAKER WAS GENERATING ANY AUDIBLE TONES AT THE TIME OF THIS MESSAGE. 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 REPORTED DESCRIPTION NOTES THAT A SPEAKER MALFUNCTION MESSAGE WAS DISPLAYED. IT IS UNK IF THE SPEAKER WAS GENERATING ANY AUDIBLE TONES AT THE TIME OF THIS MESSAGE.
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 |