FDA Adverse Event
Other
Summary report: N
GOODMAN CO. LTD
MDR report key: 850733
·
Received February 28, 2007
Report
- Report Number
- 2243801-2007-00009
- Event Type
- Other
- Date Received
- February 28, 2007
- Date of Event
- January 30, 2007
- Report Date
- February 26, 2007
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THIS INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE RETURNED UNIT PASSES ALL CONTINUITY TESTING AND WAS NOTED TO FUNCTION PROPERLY. NO DEFECTS WERE NOTED IN THE RETURNED UNIT. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.
Description of Event or Problem · 1
PACING FAILURE. UNABLE TO PRODUCE A WAVE FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO. LTD | PACING CATHETER | DYB | B. BRAUN MEDICAL, INC. | NA | 60798888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |