HEARTSINE SAMARITAN PAD 350P

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. THE CUSTOMER'S DEVICE WAS NOT RETURNED TO HEARTSINE FOR EVALUATION. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

Description of Event or Problem

THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.