FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2002669
·
Received February 9, 2011
Report
- Report Number
- 9610816-2011-00032
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Report Date
- January 13, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE MONITORS' ALARMS WERE TURNING OFF WITHOUT USER INTERFACE. NO PT HARM WAS REPORTED. THE LOCAL PHILIPS SERVICE STAFF PERSON VERIFIED THAT THE MONITORS INVOLVED FUNCTION AS INTENDED AND HAD NO INTERNAL ERRORS INDICATIVE OF ANY PAST PROBLEMS. 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 MONITORS' ALARMS WERE TURNING OFF WITHOUT USER INTERFACE. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP70 INTELLIVUE PATIENT MONITOR | DSI | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |