[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 â— 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
©2019 ECRI
Institute
5200 Butler
Pike, Plymouth Meeting, PA 19462-1298, USA
May be
reproduced by subscribing institution for internal distribution only.