FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1180545
·
Received May 23, 2008
Report
- Report Number
- 3003768251-2008-00003
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
- Product Code
- LLZ
- PMA / PMN Number
- k964124
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
EVAL METHOD, RESULTS AND CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | LLZ | PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |