HEARTSINE SAMARITAN PAD 350P

Additional Manufacturer Narrative

THE ADDITIONAL INFORMATION ON THE PATIENT WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. HEARTSINE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

Description of Event or Problem

THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE HAD AN INTERMITTENT CONNECTION TO THE PATIENT AND DID NOT PERFORM AS EXPECTED DURING THE EVENT. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.