FDA Adverse Event
Malfunction
Summary report: N
MP50 INTELLIVUE PATIENT MONITOR
MDR report key: 2020469
·
Received February 16, 2011
Report
- Report Number
- 9610816-2011-00101
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Report Date
- January 25, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED AN INTERMITTENT SPEAKER INOP WITH THE BEDSIDE MONITOR. NO PT HARM WAS REPORTED. THE AVAILABLE INFORMATION IS NOT SUFFICIENT TO DETERMINE IF THERE WAS AN AUDIO FAILURE. 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 AN INTERMITTENT SPEAKER INOP WITH THE BEDSIDE MONITOR. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP50 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8004A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |