The Food and Drug Administration (FDA) has alerted providers and other users to a recall of HeartStart MRx monitor/defibrillators due to electrical and battery connection issues.
According to the FDA, the Phillips defibrillator might not power up, charge, or deliver electrical shock therapy, and could unexpectedly stop pacing. This could delay electrical therapy and result in serious patient harm.
The recall affects monitor/defibrillators distributed from Feb. 11, 2004, to Nov. 4, 2016. In February, the company sent a safety notice to all affected customers instructing them to:
- identify affected devices using the model number information;
- inspect that the battery connector pins are clean, fully extended, and free of residue;
- review the information with other staff trained to use the defibrillator; and
- complete and return the Confirmation Response included with the notice.
FDA advises health care professionals to report adverse events or side effects related to the electrodes to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. Questions about the recall should be directed to Phillips Healthcare, at 800.722.9377.