Device product
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0004-2017
Product summary
- Event
- Event 75181
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,110 ( US 8,040; OUS 3,070)
- Official record key
device-enforcement:Z-0004-2017
Official wording
Reason: There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Code information: US: 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-0771; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.
Distribution pattern: Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.
Derived failure modes
-
Unknown
There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.