Device product
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Z-0462-2015
Product summary
- Event
- Event 69752
- Status
- Terminated
- Classification
- Class I
- Quantity
- 174,610 (168,090 US and 6,520 OUS) in total.
- Official record key
device-enforcement:Z-0462-2015
Official wording
Reason: Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
Code information: All Lot Codes
Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.
Derived failure modes
-
Unknown
Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.