LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)

Additional Manufacturer Narrative

THE CUSTOMER RECEIVED A REPLACEMENT SET OF PADDLES. STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. STRYKER REQUESTS PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. THE CUSTOMER INFORMED STRYKER THAT NO FURTHER PATIENT INFORMATION IS AVAILABLE. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

Description of Event or Problem

THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S INTERNAL PADDLES DID NOT DELIVER A SHOCK. A 2ND SET WAS USED TO DELIVER THE SHOCK. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.