FDA Adverse Event
Malfunction
Summary report: N
MP50 INTELLIVUE PATIENT MONITOR
MDR report key: 2002670
·
Received February 9, 2011
Report
- Report Number
- 9610816-2011-00069
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Report Date
- January 13, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM FOR A LOW HEART RATE. NO PT HARM WAS REPORTED. 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 THERE WAS A FAILURE TO ALARM FOR A LOW HEART RATE. 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 |