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FDA does not endorse either the product or the company.
Contact
Consumer:
877-877-0147
FOR IMMEDIATE RELEASE – October
24, 2012 – On September 13, 2012, HeartSine Technologies, Ltd.
initiated a voluntary global correction of certain Samaritan®
300/300P PAD public access defibrillators to address two separate
issues that may affect the ability to deliver therapy to a patient
in a sudden cardiac arrest (SCA) event, if needed. Certain
Samaritan® 300/300P PAD devices manufactured before December
2010 have been found to intermittently turn on and off, which may
eventually deplete the battery. In addition and separately, certain
Samaritan 300/300P PAD devices containing early versions of the
battery management software may misinterpret a temporary drop in
battery voltage as signaling a low battery and subsequently turn
the device off. In certain instances, a device experiencing either
condition could be unable to deliver therapy during a cardiac
event.
The potentially affected Samaritan 300/300P PADs were
manufactured from August 2004 to December 2010 and have a warranted
life of 7 years. Samaritan® 300/300P PAD devices with the
following serial numbers inclusive are affected by one or both
these issues:
- 0400000501 to 0700032917
- 08A00035000 to 10A00070753
- 10C00200000 to 10C00210106
Because a device experiencing the on/off issue will function
appropriately if it has an adequate power source, HeartSine is
sending affected customers a new PAD-PAK to be held in reserve and
an accompanying hang tag with instructions for when and how to
insert the reserve PAD-PAK so that the customer always has the
ability to deliver therapy in a rescue attempt. In addition,
HeartSine is providing a software upgrade (with a CD, data cable
and associated User Manual) to bring all users up to a more recent
version of the software that the company’s data shows is no
longer susceptible to the secondary issue.
HeartSine has requested that customers take the following
actions to ensure that they are able to provide therapy in the
event that a sudden cardiac arrest event occurs:
- Keep the device(s) in service.
- If necessary, relocate the Samaritan® 300/300P PAD to an
area where the audible prompts would be heard if initiated. - Immediately increase device check frequency to daily to confirm
that the Samaritan 300/300P PAD is operable and in ready standby
mode. - If the device is not in ready standby mode, contact HeartSine
Technologies at 1-877-877-0147 immediately so that a replacement
unit can be sent. - Always have a reserve PAD-PAK on hand. Place the supplied
reserve PAD-PAK in the zippered pouch on the back of the Samaritan
300/300P PAD soft carrying case and attach the provided hang-tag to
the handle of the Samaritan 300/300P PAD soft carrying case to
alert a first responder when and how to insert the reserve PAD-PAK
if the installed PAD-PAK appears to have been depleted and the
device is needed in a rescue attempt. Instructions for replacing
the PAD-PAK are provided on the hang-tag. - Update the device software using the supplied data cable and CD
(or via the company’s website at http://www.heartsine.com/recall/software_updates
). Replace the originally
supplied User Manual, stored in the soft carry case, with the new
copy supplied with this field action. - If the device is needed in a sudden cardiac arrest event and
the LED is red or unlit, replace the PAD-PAK with the reserve
PAD-PAK according to the instructions on the hang tag. Once the
reserve PAD-PAK has been inserted, therapy can be delivered.
Following the event, HeartSine Technologies should be contacted
immediately at 1-877-877-0147.
The firm voluntarily issued a correction for this product after
becoming aware of the above issue. FDA is aware of the action and
the steps the company is taking. No deaths or injuries have been
reported to date associated with the on/off issue. To date,
HeartSine has received five reports of death for which the company
has not been able to rule out the possibility that the events may
have been related to the battery management software issue.
Consumers with questions may contact the company at
1-877-877-0147 between the hours of 8:00am and 5:00 pm ET and email
at
heartsine6265@stericycle.com.
Adverse reactions or quality problems experienced with the use
of this product may be reported to FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
(form available to fax or mail), or - Call FDA 1-800-FDA-1088
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