Cause of Device-Related Incident
Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical/Biomedical Engineering; Emergency Medicine; Nursing

Device Factors
*Not stated

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Electrical shock / electrocution

Support System Failures
Failure to train and / or credential

Tampering and/or Sabotage
*Not stated

User Errors
Incorrect clinical use

UMDNS
Defibrillator/Monitors [11-129]

Misuse of "Quick-Look" Defibrillator Paddles



Hazard [Health Devices Feb 1988;17(2):68-9]

Problem

A hospital reported to us a case in which misuse of a defibrillator/monitor equipped with external "quick-look"* paddles led to injury of a nursing assistant, who had held the paddles to her own chest to check the defibrillator's ECG monitor. While positioning the paddles, she accidentally charged and discharged the defibrillator, shocking herself and receiving burns at the paddle contact sites. In addition, she suffered recurring cardiac arrhythmias, possibly from the shock. In the same hospital, misuse of the rapid ECG-monitoring feature on the quick-look paddle resulted when users substituted the paddle tracings for routine diagnostic ECGs. The hospital encouraged this practice to save the cost of disposable ECG electrodes and may have influenced the assistant's actions.

The hospital also stated that other inadvertent discharges occurred when manufacturers' technicians placed paddles on themselves to check the defibrillator's ECG monitor, rather than connecting the patient lead cable to an ECG simulator.

Lack of familiarity with defibrillators, accidental discharge of defibrillators, or inappropriate use of the quick-look paddles may injure or kill a user or patient.

Discussion

The quick-look paddle feature is designed for initial, rapid ECG assessment during cardiac resuscitation only. Most defibrillator/monitors have paddles with this feature, but their monitors typically accept a 3- or 5-lead patient ECG cable as well. ECG monitoring through these leads is the correct way to obtain short-term ECG data (e.g., during patient transport, after defibrillation) as well as a recommended method of determining whether defibrillation is needed. The leads may also be used to check monitor operation during device inspection or repair.

Some units also have hard-copy recorders that can produce diagnostic-quality (0.05-100 Hz bandwidth) ECG tracings. However, if quick-look paddles are used in this mode, their tracings will not be of diagnostic quality because of the limited bandwidth (typically 0.5-40 Hz) of the paddle monitoring feature. Substituting paddle tracings for routine diagnostic ECGs could result in misdiagnosis and inappropriate therapy.

Manufacturers recommend using the quick-look paddle monitoring feature for immediate ECG assessment only. Users should then connect the patient to the defibrillator's ECG monitor with ECG leads for short-term monitoring. Unless it is designed specifically for recording diagnostic ECGs (i.e., includes a diagnostic ECG mode used with an appropriate patient cable for recording full diagnostic multiple-lead ECGs), a defibrillator's ECG monitor should not be used for routine diagnostic ECGs. Most manufacturers also recommend using a patient ECG lead cable for synchronized cardioversion. If an ECG is taken through the paddles for this purpose, electrical artifacts are generated on the ECG waveform that can inhibit correct triggering.

Safe and effective use of quick-look paddles and their rapid-ECG-monitoring feature requires proper user training. Hospitals should not permit unqualified personnel to operate, inspect, or service defibrillator/monitors. ECG electrode cost-saving policies should not encourage misuse of the monitoring feature or the paddles.

Recommendations

  1. Warn defibrillator/monitor users that they should never test paddles or monitoring operation by applying external defibrillator paddles to their chest.
  2. Ensure that only trained personnel use these devices. These paddles deliver dangerous electrical shocks. Never charge the unit until ready to defibrillate a patient or discharge the defibrillator into a test load. Use the quick-look paddle monitoring feature for initial, rapid ECG assessment during an emergency or a resuscitation attempt only. If the defibrillator's ECG monitor does not appear to be functioning properly during rapid ECG assessment through the paddles, connect the ECG leads to the patient to obtain an ECG. If the monitor still does not function, use another unit.
  3. Do not perform short-term or routine ECG monitoring using the quick-look paddle monitoring feature; use the ECG leads supplied with the device for such applications and for synchronized cardioversion. When full diagnostic tracings are required, use a standard electrocardiograph or a defibrillator/monitor with a diagnostic ECG mode and the special cable and monitoring electrodes required.
  4. To test the quick-look paddle monitoring feature, clinical engineering personnel should connect or contact the paddles to an ECG simulator. Be sure the defibrillator is discharged and turned off if you have to touch the paddle electrode surfaces or ECG circuit, and keep the defibrillator off and uncharged while testing the ECG function. Use a patient lead cable and a simulator that does not require applying the ECG signal to the paddles to check the defibrillator's ECG monitor operation.

* The generic term "quick-look" as used in this discussion should not be confused with the trade name Quik-Look used by Physio-Control for this model of defibrillator paddles.

UMDNS Term

Defibrillator/Monitors [11-129]

Cause of Device-Related Incident

User error: Incorrect clinical use

Support system failure: Failure to train and/or credential

Mechanism of Injury or Death

Burn; Electrical shock/electrocution


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