FDA Adverse Event
Other
Summary report: N
CODEMASTER XL
MDR report key: 306240
·
Received November 22, 2000
Report
- Report Number
- 1218950-2000-00228
- Event Type
- Other
- Date Received
- November 22, 2000
- Report Date
- October 24, 2000
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE FOLLOWING PROBLEM WAS REPORTED TO AGILENT TECHNOLOGIES: THE PT WAS ABLE TO BE MONITORED THROUGH PADDLE SOURCE, BUT NOT ABLE TO BE MONITORED THROUGH LEAD SOURCE. DASHED LINES APPEARED. THE NURSES CHANGED THE LEAD SET; THEY WERE THEN ABLE TO MONITOR THROUGH LEAD SET SOURCE. THERE WAS NO ADVERSE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODEMASTER XL | DEFIB/MON/REC | LDD | AGILENT TECHNOLOGIES, INC. | M1722A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |