FDA Adverse Event
Malfunction
Summary report: N
ISITE PACS
MDR report key: 2259951
·
Received August 26, 2011
Report
- Report Number
- 2954704-2011-00010
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 11, 2011
- Manufacturer
- PHILIPS HEALTHCARE INFO, INC
- Product Code
- LLZ
- PMA / PMN Number
- K042292
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ADD'L INFO WAS RECEIVED ON (B)(4) 2011, AT WHICH TIME THE TICKET WAS MADE INTO A COMPLAINT. CUSTOMER REPORTED THAT IQUERY RETURNED INCORRECT RESULTS. WHILE PERFORMING A QUERY BY PT NAME, MULTIPLE RESULTS WERE SHOWN. ONE OF THE ASSOCIATED MRNS WAS FOUND TO BE FOR TWO DIFFERENT PTS. ROOT CAUSE INVESTIGATION IS IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISITE PACS | ISITE PACS | LLZ | PHILIPS HEALTHCARE INFO, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |