HEARTSINE SAMARITAN PAD 350P

Description of Event or Problem

THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT RECOGNIZE A CONNECTION THROUGH ITS DEFIBRILLATION ELECTRODES. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

Additional Manufacturer Narrative

HEARTSINE CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. HEARTSINE REQUESTS PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. THE CUSTOMER PROVIDED HEARTSINE WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. HEARTSINE CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.