Device product
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
Z-2115-2014
Product summary
- Event
- Event 68703
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3245
- Official record key
device-enforcement:Z-2115-2014
Official wording
Reason: A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Code information: Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
Distribution pattern: Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Derived failure modes
-
Unknown
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.