Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall 12Lead ECG Cable

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall 12Lead ECG Cable see related information
Date Initiated by Firm May 11, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on August 12, 2011
Recall Number Z-2625-2011
Recall Event ID 58822
510(K)Number K973486  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 12-lead ECG Cable Assembly contains the following cable and attachments:

Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs.

Precordial Lead Attachment: The precordial lead attachment includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps).

This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is not
connected.

This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the Emergency Department.
Code Information 12-lead ECG Cable with Limb Lead Attachment Part Numbers: 3302822-000-AHA; 3302822-002-AHA; 3302822-001-IEC; 3302822-003-IEC.  Precordial Lead Attachment Part Numbers: 3302823-000-AHA and 3302823-001-IEC.  No Serial numbers for 12-Lead ECG Cable.
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact Tech Support
800-442-1142 Ext. 5
Manufacturer Reason
for Recall		 The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications.
FDA Determined
Cause 2		 Device Design
Action Physio-Control, Inc. sent an "URGENT-MEDICAL DEVICE ACCESSORY INFORMATION" letter dated May 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The customers were advised to follow the instructions: -Use standard hard paddles or therapy electrodes for ECG monitoring if monitoring cannot be performed using the ECG cable. Refer to Troubleshooting Tips for ECG Monitoring in the LIFEPAK 12 or LIFEPAK 15 Operating Instructions-Monitoring chapter. -Disconnect the ECG cable from the monitor after use and coil it loosely for storage. Please refer to the Storage Instructions for 12-lead ECG Cable. -Inspect cables daily for bulges which may indicate damaged internal wires. If bulges are visible, replace the ECG cable. -Perform periodic 6 month function testing: Refer to Maintenance and Testing Schedule in the LIFEPAK 12 or LIFEPAK 15 Operating Instructions- Maintaining the Equipment chapters for instructions on how to perform a patient ECG cable function check to confirm proper operation of the cable. Customers can visit Physio-Control's website at www.physio-control-notices.com/12LeadECG for additional information or to download copies of current LIFEPAK 12 defibrillator/monitor or LIFEPAK 15 monitor/defibrillator Operating Instructions and Operator's checklists. Customers can also call Physio-Control's Technical Support Team at 1-800-442-1142, option 5, from 6:00 A.M. to 4:00 P.M. (Pacific), Monday-Friday.
Quantity in Commerce 21,825 units distributed worldwide
Distribution Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL CORP.
-
-