| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| LIFEPAK 20 Defibrillators/Monitors; Software versions: 28, 30, 32, 38 | Part Number: 3202487-015 | Serial Number: 33818710. See http://www.medtronic-ers.com/notices/20-lock-up to verify all other affected Serial Numbers and Part Numbers as applicable. |
8,698 units total. | Not Specified |
 |
AED Recalls
| Alert Details for #2006120277 (Released 12/18/2006 17:46 EST) | |
| Description: | LIFEPAK 20 Defibrillators/Monitors; Software versions: 28, 30, 32, 38 |
|---|---|
| Manufacturer: | Medtronic Emergency Response Systems, Redmond, WA |
| Reason: | The device can experience a lock-up condition which could cause an unacceptable delay in the delivery of a defibrillating shock, which could possibly result in failure to resuscitate a patient. |
| Analyst Comments: | The attached manufacturer's notice dated December 2006 was submitted by a RASMAS subscriber. Please note that this notice may be specific to the subscriber to whom it was sent and may cover additional products and lot numbers. If you stock this item, please contact the manufacturer for additional information. See http://www.medtronic-ers.com/notices/20-lock-up/ to verify all other affected Serial Numbers and Part Numbers as applicable. The lock-up appears as if the device will not turn on with the battery power. The display is blank and all indicators are off. The most common scenario for experiencing a device lock-up is during routine user testing when AC power is disconnected, followed by the device being immediately turned on to perform the user tests on battery power. There have been 16 confirmed occurrences during user testing and 1 confirmed occurrence during patient use. The opportunity for a lock-up condition can only occur if the device is turned on between 0.6 and 1.7 seconds after disconnecting the device from AC power. Please follow operating instructions immediately: Connect to AC power if the device does not operate on battery power. To prevent lock-up Turn on the device prior to removing AC power. Immediate Recommendations if lock-up occurs: Immediately reconnect to AC power to restore normal operation. Medtronic to follow-up in January 2007 to provide a software upgrade to all devices to correct lock-up issue. Medtronic recommends to continue using the device until the update of the device software. Contact Medtronic at 1-800-442-1142, 425-867-4000, or http://www.medtronic-ers.com. |
| Alert Type: | Field Correction URGENT | Source Alert Type: | Not Classified by Source |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | Manufacturer |
| Distribution: | Worldwide | Source Date: | 12/18/2006 |
| Links: |
|---|
| AED2006120277.pdf |
| Product Information |