Device Recall LIFEPAK 20 defibrillator 의 리콜

Recall

60202

Class 2

Z-0185-2012

2008-12-30

2011-11-16

Terminated

United States

2011-11-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104736

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.

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 cable, the test plug signal can be misinterpreted as a patient waveform. Recommendations to users who use a Therapy Cable: -Disconnect the QUIK-COMBO test plug prior to patient use -Confirm therapy electrodes - to - therapy cable connection -Confirm therapy cable - to - defibrillator connection -Confirm therapy electrodes - to - patient connection Adding 2005 American Heart Association software that includes audible and visual prompts to LIFEPAK 20 defibrillators manufactured prior to January 2007 is optional and not required. If the customers would like to have this optional kit installed in your defibrillators, please contact Physio Control, Inc. Customers can call Technical Support at 1-800-442-1142 for any questions about this recall or or visit our website at www.physio-control notices.com/LP20testplug.