FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE CLINICAL INFORMATION RELEASE E
MDR report key: 2221919
·
Received August 17, 2011
Report
- Report Number
- 1218950-2011-02252
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Report Date
- July 28, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- DXJ
- PMA / PMN Number
- K100272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT NEW ORDERS ARE NOT DISPLAYED IN THE FLOW SHEET. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 NEW ORDERS ARE NOT DISPLAYED IN THE FLOW SHEET. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE CLINICAL INFORMATION RELEASE E | DXJ | PHILIPS HEALTHCARE - ANDOVER | 865209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |