FDA Adverse Event
Malfunction
Summary report: N
MP50 INTELLIVUE PATIENT MONITOR
MDR report key: 1893685
·
Received November 2, 2010
Report
- Report Number
- 9610816-2010-00689
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Report Date
- October 1, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM FOR DESATURATION. NO PT HARM WAS REPORTED. THE AVAILABLE INFORMATION INDICATES THAT A USER INHIBITED THE ALARM, BUT PHILIPS DOES NOT HAVE ENOUGH INFORMATION TO EXCLUDE A POSSIBLE HEALTH RISK. PHILIPS HAS NOT BEEN INFORMED OF THE ALARM DELAY CONFIGURATION FOR SPO2 ALARMING ON THIS MONITOR. 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. 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 |