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

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

AED/DPS-12/15/10-RXS

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

AED/DPS-12/15/10-RXS

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

AED/DPS-12/15/10-RXS

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%)

AED/DPS-12/15/10-RXS

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%)

AED/DPS-12/15/10-RXS

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%)

AED/DPS-12/15/10-RXS

slide12
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

AED/DPS-12/15/10-RXS

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

AED/DPS-12/15/10-RXS

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”.

AED/DPS-12/15/10-RXS

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”

AED/DPS-12/15/10-RXS

postmarket surveillance
Postmarket Surveillance
  • We need your reports for postmarket surveillance!
  • www.fda.gov for how to report and to access MAUDE MDR database

AED/DPS-12/15/10-RXS

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