FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK EXPRESS DEFIBRILLATOR
MDR report key: 1232111
·
Received November 4, 2008
Report
- Report Number
- 3015876-2008-01574
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- October 25, 2007
- Report Date
- October 31, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.
Description of Event or Problem · 1
PHYSIO-CONTROL WAS INFORMED BY SUPPLIER ANALOG DEVICES THAT THE FABRICATION METHOD OF CHIP-ON-LEAD (COL) PACKAGES MAY RESULT IN SILVER MIGRATION CAUSING PART FAILURE. THE COL COMPONENT IS USED IN THE LP EXPRESS AED ALONSO PCB ASSEMBLY. THERE HAVE BEEN NO REPORTED INSTANCES OF THIS OCCURRING IN THE FIELD. IF IT WERE TO OCCUR, IT COULD RESULT IN LOSS OF PATIENT IMPEDANCE, CAUSING DEFIBRILLATION TO BE DELAYED AND/OR NOT DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK EXPRESS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | EXPRESS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |