Device product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
Z-1175-2018
Product summary
- Event
- Event 79337
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,720 units in total
- Official record key
device-enforcement:Z-1175-2018
Official wording
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Code information: Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
Derived failure modes
-
Unknown
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure