Adverse event reports for external defibrillators 2005 2010
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Adverse Event Reports for External Defibrillators 2005 – 2010. Roberta Sullivan, BSN, MPH Nurse Consultant, MDR Analyst Office of Surveillance and Biometrics Division of Postmarket Surveillance Product Evaluation Branch I. Introduction. Medical Device Report (MDR) Mandatory - Form 3500A

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Adverse Event Reports for External Defibrillators 2005 – 2010

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Adverse event reports for external defibrillators 2005 2010

Adverse Event Reportsfor External Defibrillators 2005 – 2010

Roberta Sullivan, BSN, MPH

Nurse Consultant, MDR Analyst

Office of Surveillance and Biometrics

Division of Postmarket Surveillance

Product Evaluation Branch I

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Introduction

Introduction

  • MedicalDevice Report (MDR)

  • Mandatory - Form 3500A

  • Voluntary MedWatch - Form 3500

  • Manufacturer and User Facility Device Experience (MAUDE)

  • http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

  • Or go to www.fda.gov -> navigate to “report a problem” online

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Mdrs received by fda from jan 1 2005 to jan 1 2010

MDRs: Received by FDA from Jan 1, 2005 to Jan 1, 2010

  • Original Product Code LDD: dc-defibrillator, low-energy, (including paddles)

    Class II, 510K cleared

    * ExternalDefibrillator, rhythm not diagnosed

    nor shock delivered automatically

  • Subsequent Product code MKJ: automated or semi-automated external defibrillators

    Class III, 510K cleared, used by lay public

    *Automatic functions, AED

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Adverse event reports for external defibrillators 2005 2010

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Adverse event reports for external defibrillators 2005 2010

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Adverse event reports for external defibrillators 2005 2010

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Adverse event reports for external defibrillators 2005 2010

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Patient problem codes

Patient problem codes

  • No patient involvement (59%)

  • No patient consequences (10%)

  • Unknown (9%)

  • Not applicable (5%)

  • No information (5%)

  • Death (4%)

  • No known impact to patient (3%)

  • Resuscitation (<1%)

  • Hospitalization required (<1%)

  • Cardiac Arrest (<1%)

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Patient problem codes1

Patient problem codes

  • No patient involvement (59%)

  • No patient consequences (10%)

  • Unknown (9%)

  • Not applicable (5%)

  • No information (5%)

  • Death (4%)

  • No known impact to patient (3%)

  • Resuscitation (<1%)

  • Hospitalization required (<1%)

  • Cardiac Arrest (<1%)

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Adverse event reports for external defibrillators 2005 2010

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Device problem codes

Device problem codes

  • Device displays error message (28%)

  • Failure to power up (15%)

  • Failure to charge, discharge or deliver (9%)

  • Loss of power (4%)

  • No display or display failure (4%)

  • Replace (4%)

  • Failure to run on AC/DC (3%)

  • Failure to shock or pace properly (3%)

  • Device issue (2%)

  • Device inoperable (2%)

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Adverse event reports for external defibrillators 2005 2010

  • If returned for analysis, the evaluation identified device failure 1 time out of 3

    (Component/subassembly failure, electrical/mechanical problem, design, contamination, manufacturing, software)

  • If returned for analysis, the conclusion was “device failure directly caused event or was related to event” ~40% of time

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What can mdr information be used for

What can MDR information be used for?

  • Provide a qualitative snapshot of adverse events for a specific device or device type

  • Signal detection

    • Unexpected events for a specific device type

    • Change in severity of expected events

    • User error/human factors issues

  • Regulatory actions

  • Premarket considerations

  • Public health communications

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Example 1

Example 1

  • “Complaint alleged that while attempting to cardiovert a pt (age and gender unknown), the device inappropriately shut down. Complainant indicated that the patient subsequently expired”.

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Example 2

Example 2

  • “Person requiring CPR, which was started by first responders. Nurse team arrived with AED, continued CPR, placed pads and hooked up to AED. Reading said "MEMORY FULL." CPR continued. Paramedics arrived with ambulance, took over CPR, intubated, inserted IV and transported to hospital. Placed on monitor en route, flatline. Pronounced upon arrival”

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Adverse event reports for external defibrillators 2005 2010

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Postmarket surveillance

Postmarket Surveillance

  • We need your reports for postmarket surveillance!

  • www.fda.gov for how to report and to access MAUDE MDR database

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