MAUDE Adverse Event Report: COVIDIEN CADENCE ZOLL ADULT RTS; DEFIBRILLATION ELECTRODES

Model Number 22770R

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with defibrillation electrodes.The customer reports that the account was testing the product and were not receiving a signal upon initial plug in.The crd was applying the product to her arm and plugging it into the crash cart to see if the machine would identify the pad.The crash cart was not identifying the pad without the crd applying pressure to the pad once it was adhered to her skin.

Manufacturer Narrative

A device history record (dhr) review was performed for product 22770r, lot number 521302x, and it passed all acceptance criteria.All electrical test results were within specification, and it passed all aql visual inspections.One complaint sample was received, and upon visual inspection (see attached photo), there were no visual defects observed.Electrical testing was also performed on the complaint sample to ensure the functionality of the defibrillation electrode.The following tests were performed on dielectric testing (current on the molded connectors), and electrical testing (on the defibrillation electrode pad).All test results passed for the complaint sample-see attached test report.Because product 22770r, lot 521302x passed the dhr review, and all sample testing, this complaint could not be confirmed.Therefore there is no manufacturing related root cause; the issue is most likely due to the method of preparation.As per the instructions for use (ifu), ensure that the product is properly stored.The electrodes should be stored in their sealed protective pouch in a cool dry place, and should be kept away from sunlight.The packaging also indicates that the product should not be used if the pouch is damaged.The pouched product should not be crushed, folded, or stored under heavy objects.There are several important factors that can impact the adhesion of the product that can result in issues related to the electrode not delivering electricity.First, improper application of the electrode or applications without proper skin preparation can cause a failure to create adequate connection between the patient and the electrodes.In order for electrical signals to pass from the body through the electrodes, an electrically conductive path between the skin and electrodes must be established to ensure adequate electrode impedance or contact impedance.Successful defibrillation requires electricity to flow from one electrode to the other through the chest.If the electrodes are not firmly adhered and there is sweat or another conductive material between the electrodes, the electricity will be more likely to flow across the chest rather than through it.Electrode pads must come in direct contact with the skin.Additionally, the packaging instructions should be followed to ensure proper adhesion of the product: remove excess hair.If the chest hair is so excessive as to prevent good adhesion of the electrode pad, the hair should be removed.Clean and dry skin sites.Do not use alcohol or tincture of benzoin.Smooth the electrode from the center outwards to the edges with fingertips to ensure that there are no air pockets between the gel and the patient¿s skin.Electrodes are not repositionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion.Second, improper connection to the therapy cord will also cause the defibrillator to fail to recognize the electrodes.Ensure that the connector and aed receptacle are free of debris and properly connected.Because this complaint is not confirmed, there are no further corrective or preventive actions required at this time.Further trending will be performed for similar reports, and this complaint will be shared with the defibrillation focus factory to promote awareness.

• Brand Name: CADENCE ZOLL ADULT RTS
• Type of Device: DEFIBRILLATION ELECTRODES
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow park drive; chicopee MA 01022
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5303430
• MDR Text Key: 34330905
• Report Number: 1219103-2015-00009
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Device Lot Number: 521302X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1