Recall Z-0185-2012 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Physio Control, Inc.
The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.
| Date | Nov 16, 2011 (initiated Dec 30, 2008) |
| Status | Terminated |
| Reason | When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. |
| Root cause | Employee error |
| Action | Physio Control sent a " Urgent Medial Device Safety Alert" letter dated January 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter instructed the customers to follow the Operating Instructions for AED and Manual Defibrillation mode (Section 4-Therapy, pages 58 and 61) that instructs users to "Connect therapy electrodes to the therapy cable and confirm cable connection to the defibrillator" to prevent users from mistakenly leaving the test plug and reconnect the QUIK-COMBO electrodes to the therapy cab |
| Quantity | 23,467 units worldwide |
| Distribution | Worldwide Distribution--USA ( nationwide ) and the countries of Bahrain, Lebanon , Cyprus, Netherlands, Egypt, Pakistan, Germany, Saudi Arabia, India, South Africa, Iran, Syria, Israel, Turkey, Jordan, UAE,Kuwait, Yemen, Asia Pacific, Australia, New Caledonia, Guam, New Zealand, Hong Kong, Lati |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER Medtronic Physio-Control Corp., Feb 5, 2002 |