MAUDE Adverse Event Report: COVIDIEN CADENCE ZOLL PRECONNECT; DEFIBRILLATION ELECTRODES

Model Number 22770R

Device Problems Failure to Discharge (1169); Device Expiration Issue (1216); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 12/23/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with defibrillation electrodes.The customer reports that during a cardiac arrest, the defibrillation pad was applied to the patient's chest, after charging, the defibrillator would not discharge.A pad disconnect message was on the screen.When examined, it was found that the electrode on the pad had separated from the backing and stayed adhered to the clear plastic.As a result, the pad would not conduct the defibrillation and the shock was delayed until another set of pads could be applied and patient was then defibrillated.The customer further reports that there was a delay in defibrillation for vf arrest state.Cpr was resumed until defibrillation pads were changed.The patients current status is reported as deceased.The electrode was not returned; however, based on pictures provided by the customer it was determined that the product was 9 years old, 7 years beyond the expiration date.Based on the extreme age of the product it is expected that the delamination was a result of product age.Customer does not blame our electrode for the cause of death.The covidien sales rep stated that she had provided samples of expired 22770r pads for educational purposes to the ccu educator a few years ago.Our thinking is that these were used on the patient although they provided the packaging of the 2nd pair of 22770pc pads used once they realized the pads were not functioning and referenced those in their report.This assumption is based on the photos of the pads in the report.These are 22770r pads not the pc pads as per the.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

This complaint report indicated that the affected product was product code 22770pc, production lot 403844x.A picture of the suspect defibrillator electrode was originally provided with the complaint.Additional pictures of the product and pouch were gathered from visits by covidien personnel to the hospital.An initial review of the pictures indicated that the actual electrodes used when the foam pad separated from the gel body was code 22770r, not 22770pc as indicated in the complaint report.Further specifics on this are denoted later in the discussion.Device history record (dhr) review was performed for the product/production lot as indicated in the complaint report.Based upon the dhr review, no abnormal run conditions were present during the manufacture of the product that could have led to the incident described by the customer.The dhr review showed that all acceptance criteria checks and tests per established sampling levels were within predefined limits during the production process.A review of the production retain samples confirmed that the product was constructed per the requirements.The complaint report indicated the actual defib electrode would not be returned for evaluation, however pictures (representing the reported malfunction) were provided.The complaint report implicated product code 22770pc, lot 403844x which is a metallic black wire product that is the leads out product (the wires are embedded within and through a football that is sealed into the pouch top seal).The product represented in the pictures is actually 22770r product which has the same type connector, however the wire is white rts (radio translucent) and is not leads out product (entire wire lead contained within the pouch).Additional evaluation of the pictures of the defibrillation electrodes revealed that these electrodes would have been.

Event Description

Produced in early 2006 or prior.More specifically, the artwork on the foam covers for the specific electrodes used on the patient was in existence from 2006 and prior.In (b)(6) 2006, the artwork noted was obsolete (b)(6) 2006.Additionally, the conductive carbon mat for the complaint pictures is according to the old dimensional configuration where it used to be larger.A change to a smaller dimensional configuration was made in (b)(6) 2011.It is also important to note that picture provided illustrates gel that has significantly yellowed and indicative of an old�el product.Based upon the review of the defibrillation electrodes that were used on the patient and had the foam pad become disengaged from the gel body, these electrodes would have expired several years prior.As such, the root cause of the noted disengagement of the foam pad to the gel body is that the product was well expired.Since the actual pouch these electrodes would have been placed into was not provided, the exact expiration of the product is not known.However, the 22770r product has a 2 year expiration date from date of manufacture.Based upon the aforementioned change control that happened to the product, the electrodes would have expired in january 2008 or prior.Based upon the investigative details and the root cause evaluation, no corrective or preventative actions are necessary at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.The product reported by the customer was 22770pc and based on the investigation the actual product is 22770r.

• Brand Name: CADENCE ZOLL PRECONNECT
• Type of Device: DEFIBRILLATION ELECTRODES
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4450402
• MDR Text Key: 5388287
• Report Number: 1219103-2015-00001
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Device Lot Number: 403844X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 82