FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE CLINICAL INFO PORTFOLIO (ICIP)
MDR report key: 2121383
·
Received May 5, 2011
Report
- Report Number
- 1218950-2011-01264
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Report Date
- April 19, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- DXJ
- PMA / PMN Number
- K992636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT ORDERS ARE NOT VISIBLE IN THE FLOWSHEET AT THE CLIENT. 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 ORDERS ARE NOT VISIBLE IN THE FLOWSHEET AT THE CLIENT. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE CLINICAL INFO PORTFOLIO (ICIP) | DXJ | PHILIPS HEALTHCARE | 865047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |