FDA Adverse Event
Death
Summary report: N
CODEMASTER XL+
MDR report key: 40304
·
Received September 26, 1996
Report
- Report Number
- 3017388-1996-00041
- Event Type
- Death
- Date Received
- September 26, 1996
- Date of Event
- September 5, 1996
- Manufacturer
- HEWLETT-PACKARD CO
- Product Code
- LDD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE OPERATOR TURNED ON THE DEFIB AND SET THE ENERGY SELECT SWITCH TO 3J, THINKING THAT IT WAS SET TO 200J BECAUSE THE OPPOSITE END OF THE POINTER ON THE SWITCH POINT TO 200J WHEN SET TO 3J. THE DEFIB WAS TESTED AT 3J. THE PADDLES WERE THEN APPLIED TO THE PT WITH 60 OHMS IMPEDANCE AND DELIVERED 3J. THE SWITCH WAS THEN MOVED TO 7J (THINKING IT WAS 360J). THE PADDLES WERE APPLIED WITH AN IMPEDANCE OF 53 OHMS AND 7J WAS DELIVERED. THE PT EXPIRED. THE UNIT WAS TESTED BY THE HOSPITAL'S BIO MED DEPT WITH NO TROUBLE FOUND. IT HAS BEEN RETURNED TO SVC IN THE EMERGENCY DEPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODEMASTER XL+ | DEFIBRILLATOR | LDD | HEWLETT-PACKARD CO | M1722B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |