FDA Adverse Event
Death
Summary report: N
CODEMASTER 100
MDR report key: 291001
·
Received August 15, 2000
Report
- Report Number
- 1218950-2000-00027
- Event Type
- Death
- Date Received
- August 15, 2000
- Date of Event
- March 22, 2000
- Report Date
- March 28, 2000
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- LDD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FOLLOWING EVENT WAS REPORTED TO AGILENT TECHNOLOGIES. WHEN THE SUPV ARRIVED ON SITE, THE PT WAS ALREADY HOOKED TO THE MONITOR, WHICH WAS DISPLAYING A MESSAGE "LOW OUTPUT". SOON AFTER THAT IT DISPLAYED THE MESSAGE "PACING FAILURE". HE THEN TRIED TO TURN THE PACING FUNCTION OFF, THEN ON AGAIN, BUT THE PACING FAILURE MESSAGE CONTINUED. HE THEN OBTAINED ANOTHER DEFIB FROM HIS TRUCK AND SWAPPED THE PADDLES TO THE NEW DEFIB. THIS ONE PACED OK. ABOUT 2 TO 3 MINUTES WERE LOST AS A RESULT OF THE PACING FAILURE ACCORDING TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODEMASTER 100 | PORTABLE DEFIB/MON | LDD | AGILENT TECHNOLOGIES, INC. | M2475B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |