FDA Adverse Event
Other
Summary report: N
2518586-2008-00001
MDR report key: 1103783
·
Received May 21, 2008
Report
- Report Number
- 2518586-2008-00001
- Event Type
- Other
- Date Received
- May 21, 2008
- Product Code
- ITX
- PMA / PMN Number
- K954028
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
PHILIPS FIELD SVC ENGINEER (FSE) WENT ON SITE TO EVALUATE THE ULTRASOUND SYSTEM AND PROBE. THE FSE INDICATED THE ULTRASOUND SYSTEM PERFORMED AS INTENDED. THE TEE PROBE WAS VISUALLY INSPECTED. THE TIP OF THE PROBE HAD MISSING PIECES FROM THE END CAP. NO ADDITIONAL TESTING OF THE PROBE WAS PERFORMED ON THE CUSTOMER SITE. PHILIPS OFFERED TO TAKE AND EVALUATE THE PROBE BUT THE CUSTOMER DECLINED TO RELEASE THE PROBE TO PHILIPS. PHILPS HAS NO RECORDS OF REPAIR ACTIVITY ON THE PROBE, HOWEVER, BIOMED ENGINEER INDICATED THE PROBE HAD PRIOR REPAIR PERFORMED BY A THIRD PARTY. THE HOSP RISK MGR, REPORTED THAT NO FURTHER MEDICAL INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |