Events

Recall of Device Recall 12Lead ECG Cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio Control, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58822
  • Event Risk Class
    Class 3
  • Event Number
    Z-2625-2011
  • Event Initiated Date
    2011-05-11
  • Event Date Posted
    2011-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100376
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    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.
  • 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.

Device

Device Recall 12Lead ECG Cable
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia.
  • Product Description
    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.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA