Urgent Medical Device Safety Information And Corrective Action for ReviveR AED
Defibtech DDU-100 Series AEDs
Here to determine your
Defibtech AED's software version
February 16, 2007
Defibtech is notifying customers that version
2.002 and earlier versions of the software in
DDU-100 Series AEDs (“Lifeline” and “ReviveR”)
may, under certain circumstances, clear a “Low
Battery” or “Replace Battery” warning
that was previously detected by an automatic
selftest. If this condition occurs, the operator
may be unaware of the low battery, and the device
may be unable to deliver a shock.
This situation can occur only in units with
low batteries. After a period of a low battery
warning, the software may stop reporting the
warning and the operator may be unaware of the
low battery condition. A low battery may have
insufficient power to deliver a shock. During
a rescue, replacing the low battery pack will
allow the unit to function normally.
The probability of this occurring is higher
when a battery is near end-of-life. Field data
indicate that battery life is typically greater
than three years.
Devices with operating software version 2.002
and earlier versions are subject to this correction.
Our records indicate you own at least one of
the identified DDU-100 Series AEDs that was initially
sold with the affected software.
Defibtech is releasing a new version of software
to correct this issue. You will be able to install
the new version of software in the field, where
the unit is deployed. Defibtech will follow up
this notification with a communication detailing
our plan to provide this software upgrade. Distribution
of this new software may take 12 to 16 weeks.
Follow the detailed instructions in the “Immediate
Recommendations” section below and Defibtech
recommends that you keep your DDU-100 Series
AED in service until your unit’s software
These recommendations apply only to units running
version 2.002 software or earlier versions.
To determine the software version of a unit,
turn the unit on, wait until the unit begins
speaking, and then press and hold the on/off
button for approximately five seconds until
the unit begins speaking again. Prior to automatically
turning itself off, the unit will speak the
version number; if the unit does not speak
a version number, the software version is 1.201.
We advise that you
perform the following
procedure immediately and then once per month
the unit’s software has been upgraded:
- Perform a manually initiated self-test:
- Press and hold the on/off button for approximately
five seconds until the unit speaks, “Performing
Unit Self-test.” Once
the unit begins to speak, release the on/off
- The unit will run a comprehensive self-test
for approximately ten seconds, report its
status, and then automatically shut off.
The unit will speak:
- “Unit OK” – the
unit and battery are rescue-ready.
- “Replace Battery Pack Now” or “Battery
Pack Low” – battery
pack is low and may not have sufficient
energy to perform a rescue. Replace battery
- “Replace Nine Volt Battery” – the
nine volt battery in the battery pack needs
to be replaced. Replace nine volt battery with
a lithium battery as described in the User
Manual and perform a second manually initiated
self-test as described above.
- If any other message is spoken, refer to
Section 5 of the User Manual (“Maintaining
and Troubleshooting the DDU-100 AED”).
If you have any questions, remove the unit
from service and contact your distributor or
Defibtech Customer Service at 1-877-453-4507
or e-mail us at firstname.lastname@example.org.
- NOTE: This procedure should only be run
once a month as described above.
Each manually initiated self-test consumes battery
- After the above test has been performed,
continue to verify the status of the AED on
a daily basis as recommended in the DDU-100
User Manual (Routine Maintenance, Section 5.2)
by checking the Active Status Indicator (ASI)
on the upper right corner of
- Flashing green ASI indicates that the unit
and battery are operational.
- Flashing red ASI or no flashing ASI indicates
the unit needs service. Remove unit from
service and follow the troubleshooting instructions
in the User Manual.
We are communicating this information to the
U.S. Food and Drug Administration (FDA) and to
international regulatory agencies.
I sincerely apologize for any inconvenience
this may cause you. If you have any questions
regarding this notification, please contact your
distributor or Defibtech Technical Support at
email@example.com or call 1-877-453-4507,
8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.
Defibtech is committed to ensuring our products
meet the highest quality standards and that our
customers are fully supported.
Glenn W. Laub, M.D.