R SERIES

Description of Event or Problem

COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED THE SIX MONTH MANUFCATURING TESTING.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL REPORT. PLEASE REFERENCE SECTION B5. BASED ON THE ADDITIONAL INFORMATION PROVIDED REPORTS OF THIS NATURE TYPICALLY DO NOT MEET ZOLL'S REPORTABILITY REQUIREMENTS. MALFUNCTION WAS OBSERVED IN A NON-CLINICAL SETTING AND FAULT WOULD BE DETECTED PRIOR TO CLINICAL USE. THE DEVICE WAS RETURNED TO ZOLL UK; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE PACE/DEFIB (PD) ENGINE. THE PD ENGINE WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

Description of Event or Problem

COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

Additional Manufacturer Narrative

JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.