MAUDE Adverse Event Report: COVIDIEN PHILIPS PRE CONNECT CADENCE DE; ELECTRODE

Model Number 22660PC

Device Problem Failure to Discharge (1169)

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

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a defibrillation electrode.The customer states that defipads were used with 3 different patients during ecv (electro cardioversion) in the cathlab.The electric charge of the defipads did not discharge.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two samples were received for evaluation.Samples were received in the form or one opened and one unopened electrode set.Upon visual inspection, there was hair attached to the opened electrode.There was also the presence of creases on the defibrillation electrode but it is important to note that the electrode was used on the patient, so those wrinkles are most likely formed during normal use.Electrical testing was performed on the complaint sample and one retain sample to verify the functionality of the defibrillation were within specification.A possible root cause can be due to the method or preparation, storage of the electrode set or the physical aed unit.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.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.Electrodes are not repositionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion.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.Finally, check for the following conditions in the aed unit: control pca failure, parameter pca failure or shock key failure.If any of these errors are observed, it is necessary to contact the aed manufacturer.Corrective actions are not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: PHILIPS PRE CONNECT CADENCE DE
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5369605
• MDR Text Key: 36074309
• Report Number: 1219103-2016-00001
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22660PC
• Device Catalogue Number: 22660PC
• Device Lot Number: 515622X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1