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1. DEFIBTECH REVIVER HOW TO
2. DEFIBTECH REVIVER SERIAL NUMBER
3. DEFIBTECH REVIVER SOFTWARE UPGRADE
4. DEFIBTECH REVIVER FULL
5. DEFIBTECH REVIVER SOFTWARE

This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient.

DEFIBTECH REVIVER SOFTWARE

This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier.

Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction

DEFIBTECH REVIVER FULL

Full instructions and recommendations are being mailed to affected customers.

DEFIBTECH REVIVER SOFTWARE UPGRADE

You can download a raw copy of the database here.RECOMMENDATION: Defibtech will provide customers with a free software upgrade.īecause the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Always cite the International Consortium of Investigative Journalists when using this data. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. The same device may have different names in different countries. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Medical devices help to diagnose, prevent and treat many injuries and diseases.

DEFIBTECH REVIVER HOW TO

Upon receipt of contact information from affected customers, Defibtech will send an upgrade kit to customers consisting of a software data card, instructions on how to perform the upgrade, and a pre-paid upgrade confirmation postcard that must be returned to Defibtech upon completionĮxplore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. All affected AEDs operating with software version 2.004 or earlier are to remain in the field and in service throughout the field action process. The field action consists of a software change to the AED.

DEFIBTECH REVIVER SERIAL NUMBER

If your DDU-100 series AED serial number DOES NOT fall within the listed range, your AED is not affected by this recall.Ī letter was also sent to the distributors and direct accounts that have received the affected product by first class mail with a prepaid, return written acknowledgement card. This information will expedite the process of upgrading your AEDs." Note: "it is very important for you to contact us either through the Defibtech website or return this card to confirm that you have received this notice. Complete and return the confirmation form via fax to 1-20. The customers were instructed to do the following:ġ) Remove the pads from the storage pouch on the back of their DDU-100 series AED and inspect the 9-digit serial number label.Ģ)Carefully note the 9-digit serial number on the back of the AED, then visit the Defibtech website at and enter their serial number to determine if their AED is affected email their serial number and contact information to or call Defibtech directly at 1-87 or 1-20 and Defibtech will inform them if their unit is affected.ģ) If their AED is affected, confirm receipt of this notification with Defibtech as soon as possible by website and/or confirmation card. The letter describes the product, problem and actions to be taken. The firm, Defibtech, sent an "URGENT MEDICAL DEVICE SAFETY INFORMATION AND CORRECTION" letter dated Mato its customers.