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Midstate EMS Agencies

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[High Priority ] – A32793 : ZOLL—Pro-padz Liquid Gel Radiolucent Electrodes Used with ZOLL R, M, E, and X Series Defibrillators: May Prevent

Delivery of Defibrillation or Pacing Therapy

[High Priority ] – A32793 : ZOLL—Pro-padz Liquid Gel Radiolucent Electrodes Used with ZOLL R, M,

E, and X Series Defibrillators: May Prevent Delivery of Defibrillation or Pacing Therapy

Medical Device Ongoing Action

Published: Monday, June 3, 2019 Last Updated: Wednesday, June 5, 2019

UMDNS Terms:

• Electrodes, Cardiac, External Defibrillator [15033]
• Defibrillator/Cardioverters  [18502] Product Identifier:

[Capital Equipment, Consumable]

Geographic Regions: Canada, France,  Germany, Italy,  U.S.

Manufacturer(s): ZOLL Medical Corp269 Mill Rd, Chelmsford, MA 01824-4105, United States

Suggested Distribution: Cardiology/Cardiac Catheterization Laboratory, Clinical/Biomedical Engineering, Critical Care, Emergency/Outpatient Services, Nursing, OR/Surgery, EMS/Transport, Materials Management

Problem:

In a May 28, 2019, Urgent Device Correction letter submitted by an ECRI Institute member hospital, ZOLL states that the above electrodes used with

ZOLL R Series, M Series, E Series, and X Series defibrillators may have been assembled incorrectly, potentially causing the defibrillators to display a “Check Pads” or “Pads Off” message and prevent the defibrillator from delivering therapy. ZOLL also states that there is no visual indication to the user on the electrodes that the product is not assembled correctly.

Action Needed:

Identify, isolate, and discontinue use of any affected product in your inventory. If you have affected product, verify that you have received the May 28, 2019, Urgent Device Correction letter and Response Form from ZOLL. Complete the Response Form, and return it to ZOLL. A ZOLL representative will contact your facility to coordinate the return and replacement of affected electrodes. Notify all relevant personnel at your facility of the information in the letter.

For Further Information:

ZOLL technical support department

Tel.: (800) 348-9011 or (978) 421-9460 Website: Click here

Comments:

• This alert is a living document and may be updated when ECRI Institute receives additional information.

Source(s):

• 2019 Jun 3. Member Hospital. May 28, 2019, ZOLL letter submitted by an ECRI Institute member hospital Download ● 2019 Jun 3. Manufacturer. The manufacturer has confirmed the information provided in the source material.
• 2019 Jun 5. BfArM (Germany). 07397/19 Download
• 2019 Jun 5. BfArM (Germany). (includes reply form) Download

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After four years of Chairing the Midstate REMSCO, Ron Simons has stepped down.  Thank You Ron for your dedication and leadership.  Our new Chairman is Raymond Jones, Ray has a long history with the REMSCO and extensive EMS and emergency services service.   Our new Vice Chair is Mellissa Hannan, Mellissa has served on the REMSCO for several years and has been active in several REMSCO committees. 

Wednesday June 5 6PM join Shannon Cayea and Mary Bogdan from Oneida Herkimer and Eastern Madison County Hospice and Palliative Care. Discuss interacting with hospice patients, their families and other emergency service agencies. We will review the general approach to a dying patient, and review legal aspects and forms DNR/MOLST. Register on line this program is 3 non core CME hours

Interested in assisting in EMS classes and Practical Skills Examinations? Sunday June 2, 630 PM EMS Training Center 14 Foery Drive Utica NY. Register on line or call 315 738 8351