FDA Adverse Event
Death
Summary report: N
PLY C-OMCP-VISUB (H3000)
MDR report key: 2196413
·
Received August 4, 2011
Report
- Report Number
- 3003768277-2011-00447
- Event Type
- Death
- Date Received
- August 4, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 5, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZF
- PMA / PMN Number
- K925302
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
PHILIPS WAS INFORMED THAT A PT DIED AFTER INJECTION OF AIR BY AN INJECTOR. INFORMATION WAS RECEIVED ON (B)(6), VIA AN EXTERNAL SOURCE, INDEPENDENT OF THE HOSPITAL AND UNRELATED TO PHILIPS WHICH LEADS PHILIPS TO THE CONCLUSION THAT AN ADVERSE EVENT INCIDENT HAS OCCURRED EARLIER AT A SITE WHERE OUR ENGINEER, APPARENTLY, SHORTLY AFTER THE INCIDENT OCCURRED WAS REQUESTED TO CHECK THE FUNCTIONALITY OF THE INJECTOR CONNECTED TO ONE OF OUR X-RAY SYSTEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLY C-OMCP-VISUB (H3000) | IZF | PHILIPS HEALTHCARE | 72238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |