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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]

Product	ZOLL Medical Corp Part No.	Lot No.
Pro-padz Liquid Gel Radiolucent Electrodes used with R, M, E, and X Series Defibrillators	8900-2105-01, 8900-2106-01	1719, 1719A, 1819

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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