FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 2113049
·
Received May 25, 2011
Report
- Report Number
- 9610816-2011-00262
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Report Date
- May 6, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED AN "ISSUE WITH SPEAKERS" ON THE X2 MONITOR. NO PT HARM WAS REPORTED. THE LIMITED INFORMATION PROVIDED THUS FAR IS NOT SUFFICIENT TO SUPPORT THERE WAS ANY MALFUNCTION OR HEALTH RISK. 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 "ISSUE WITH SPEAKERS" ON THE X2 MONITOR. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | PHILIPS MEDICAL SYSTEMS | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |