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DEFIBRILLATION PADS (2016-01-27)
- Starting date:
- January 27, 2016
- Posting date:
- February 8, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57024
Affected Products
DEFIBRILLATION PADS
Reason
On March 8, 2015, a distributor reported, a problem with 9131-001 electrodes was found during incoming inspection. When the lid of the AED was opened the AED immediately prompted "do not touch patient, analyzing rhythm" and skipped the initial prompts to place electrodes on the patient. Testing found 41 of the 42 electrodes returned from the distributor had higher than normal impedance. All of the affected electrodes were from lot 141125-02. The manufacturer of the electrodes was notified and 35 of the 42 electrodes were sent to them for evaluation. They noted visual differences in the appearance of the high impedance electrodes compared to normal electrodes. Their retention electrode sample from the manufacturing lot was tested and it didn't have abnormal impedance. Samples from the next 3 electrode lots received from the electrode manufacturer had normal impedance and it appeared the reported problem was limited to one customer. After additional confirmed reports of high impedance electrodes from lot 141125-02 were received from other customers, a supplier corrective action was issued in October 2015 to the electrode manufacturer. The manufacturer was able to reproduce the high impedance problem with retention samples of the hydrogels used to make lot 141125-02 electrodes. The increase in electrode impedance was a result of hydrogel transformation in 2 lots used during production and the data indicated that over time the impedance of electrodes made with these 2 hydrogel lots would continue to increase. The manufacturer's analyses of production records indicated the 2 hydrogel lots were used in the production of approximately 681 (5.6%) of the 12,096 electrodes manufactured in lot 141125-02. The field corrective action is being performed because the impedance of approximately 5.6% of the electrodes from lot 141125-02 will continue to rise over time and could eventually exceed Cardiac Science's internal impedance limit and cause the AED to fail routine electrode self-test prior to the electrode's labeled expiration date. If this occurs the electrodes will need to be replaced earlier than the indicated expiration date. It is standard and correct behavior for a Powerheart G3 AED to fail electrode self-test when the impedance limit has been exceeded. Customers are notified the AED isn't ready for use because the status indicator will turn red. The AED will return to its rescue ready state when the electrodes are replaced. The Powerheart G3 AED’s are designed to perform daily, weekly, and monthly self-tests automatically. Self-tests are also performed when the AED's lid is closed which is done every time electrodes are replaced. The lot 141125-02 electrodes don't change how the AED functions and its ability to perform routine self-tests. In summary, the purpose of the corrective action is to replace electrodes from one lot because a portion of them will expire prior to the expiration date labeled on the electrode pouch. The impedance issue doesn't affect all electrodes in the lot and the affected electrodes can still be used in a rescue if they haven't exceeded the impedance limit.
Affected products
DEFIBRILLATION PADS
Lot or serial number
141125-02
Model or catalog number
9131
Companies
- Manufacturer
-
Cardiac Science Corporation
N7W22025 JOHNSON DRIVE
WAUKESHA
53186
Wisconsin
UNITED STATES