FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP)
MDR report key: 3090256
·
Received April 19, 2013
Report
- Report Number
- 1218950-2013-01438
- Event Type
- Malfunction
- Date Received
- April 19, 2013
- Report Date
- March 21, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DXJ
- PMA / PMN Number
- K992636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PARACETAMOL PRESCRIPTION WAS CREATED WITH A 6HR SCHEDULE BUT ONLY TWO SCHEDULED TIMES WERE AVAILABLE ON THE KARDEX. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169447 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO (ICIP) | DXJ | PHILIPS MEDICAL SYSTEMS | 865047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |