FDA Failure Report
BRAND NAME LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES TYPE OF DEVICE EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR BASELINE BRAND NAME LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES BASELINE GENERIC NAME EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR BASELINE CATALOGUE NUMBER VLP12-02 BASELINE MODEL NUMBER 12 BASELINE DEVICE FAMILY LP12 BASELINE DEVICE 510(K) NUMBER K973486 IS BASELINE PMA NUMBER PROVIDED?</< TH> NO BASELINE PREAMENDMENT? NO TRANSITIONAL? NO 510(K) EXEMPT? NO SHELF LIFE(Months) NA DATE FIRST MARKETED 03/15/1998 MANUFACTURER (Section F) MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS ROAD NE POST OFFICE BOX 97006 REDMOND WA 98073 9706 MANUFACTURER (Section D) MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS ROAD NE POST OFFICE BOX 97006 REDMOND WA 98073 9706 MANUFACTURER CONTACT BILL GARTHE PRODUCT ANALYST 11811 WILLOWS RD NE POST OFFICE BOX 97006 REDMOND , WA 98073-9706 (425) 867 -4000 DEVICE EVENT KEY 425713 MDR REPORT KEY 436775 EVENT KEY 413349 REPORT NUMBER 3015876-2002-00505 DEVICE SEQUENCE NUMBER 1 PRODUCT CODE LDD REPORT SOURCE MANUFACTURER SOURCE TYPE HEALTH PROFESSIONAL,USER FACILITY,COMPANY REPRESENTATIVE EVENT TYPE MALFUNCTION TYPE OF REPORT INITIAL REPORT DATE 12/26/2002 1 DEVICE WAS INVOLVED IN THE EVENT   1 PATIENT WAS INVOLVED IN THE EVENT   DATE FDA RECEIVED 12/31/2002 IS THIS AN ADVERSE EVENT REPORT? NO DEVICE MODEL NUMBER 12 DEVICE CATALOGUE NUMBER VLP12-02 DEVICE AGE 4.5 YR DATE MANUFACTURER RECEIVED 12/26/2002 WAS DEVICE EVALUATED BY MANUFACTURER? DEVICE NOT RETURNED TO MANUFACTURER DATE DEVICE MANUFACTURED 03/01/1998 IS THE DEVICE SINGLE USE? NO TYPE OF DEVICE USAGE REUSE
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION REPORT DATE: 12/26/2002  MDR TEXT KEY: 1515616 Patient Sequence Number: 1 PARAMEDICS ATTENDED TO A PT DIAGNOSED IN CARDIAC ARREST. THE PT'S DOWNTIME WAS NOT KNOWN. WHILE MONITORING THE PT'S ECG USING DISPOSABLE DEFIBRILLATION/PACING/ECG ELECTRODES, THE DEVICE ALLEGEDLY DISPLAYED THE ECG INTERMITTENTLY. THE OPERATOR MANIPULATED THE DEFIBRILLATION CABLE NEAR THE DEVICE CONNECTOR AND WAS ABLE TO OBTAIN A CONSISTENT ECG TRACE AND DIAGNOSE THE PT AS ASYSTOLIC. WHEN THE OPERATOR ATTEMPTED TO ADMINISTER EXTERNAL PACING THERAPY USING THE DEVICE, A CONNECT ELECTRODES MESSAGE WAS ALLEGEDLY DISPLAYED AND USE OF THE DEVICE WAS INHIBITED. THE PT WAS NOT RESUSCITATED. THE REPORTER INDICATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON AN ASSESSMENT OF THE PT'S CONDITION.   ADDITIONAL MANUFACTURER NARRATIVE REPORT DATE: 12/26/2002  MDR TEXT KEY: 1515617  THE HOSP BIOMEDICAL ENGINEERING STAFF EVALUATED THE DEVICE. AN INTERMITTENT OPEN HIGH VOLTAGE CONDUCTOR WAS ALLEGEDLY OBSERVED IN THE DEVICE THERAPY CABLE.
www.accessdata.fda.gov.htm