LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)

Description of Event or Problem

A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY WHEN USED WITH INTERNAL PADDLES. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

Additional Manufacturer Narrative

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 PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.