FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP)
MDR report key: 1961485
·
Received January 10, 2011
Report
- Report Number
- 1218950-2010-02746
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Report Date
- December 20, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- DXJ
- PMA / PMN Number
- K992636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE "DISPLAY WAS FAILING DOWN". NO PT HARM WAS REPORTED. PHILIPS DOES NOT DISTRIBUTE TO MONITOR OR MONITORING HARDWARE THAT CUSTOMERS UTILIZE WITH THIS SOFTWARE PRODUCT. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. THE 3RD PARTY RESOLUTION OF THIS ISSUE HAS NOT BEEN COMPLETED. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE "DISPLAY WAS FAILING DOWN". NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP) | DXJ | PHILIPS HEALTHCARE | 865047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |