FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP)
MDR report key: 1873532
·
Received October 14, 2010
Report
- Report Number
- 1218950-2010-01665
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Report Date
- September 16, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- DXJ
- PMA / PMN Number
- K992636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PT DID NOT RECEIVE A PRESCRIBED MEDICATION AND IT DID NOT REGISTER IN THE MEDICAL ADMINISTRATION RECORD (MAR). 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 A PT DID NOT RECEIVE A PRESCRIBED MEDICATION AND IT DID NOT REGISTER IN THE MEDICAL ADMINISTRATION RECORD (MAR). 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 |