FDA Adverse Event
Other
Summary report: N
PEDIA SAT OXIMETRY CATHETER
MDR report key: 793550
·
Received November 30, 2006
Report
- Report Number
- 6000002-2006-00691
- Event Type
- Other
- Date Received
- November 30, 2006
- Date of Event
- November 2, 2006
- Report Date
- November 3, 2006
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DQE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6: DEVICE WAS NOT RETURNED OR EVALUATION.H6. DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A TWO-MINUTE RUN OF SUPRAVENTRICULAR TACHYCARDIA MOST LIKELY CAUSED BY THE GUIDEWIRE (40 CM X 0.018) BEFORE INSERTING THE PEDIASAT CATHETER. IT WAS STATED THAT IT WAS RESOLVED WITH ONE DOSE OF LIDOCAINE. PT WAS FINE AFTERWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDIA SAT OXIMETRY CATHETER | OXIMETRY CATHETER | DQE | EDWARDS LIFESCIENCES | XT245HS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Other |