MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550R

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.The device history record (dhr) was reviewed for product 22550r, lot 605025x, and passed all acceptance criteria.The expiration of the finished product is february 18, 2018.The product was still within the expiration period.No adverse conditions, special circumstances, or events were documented that may have led to the adhesion issue as described by the customer.In addition, the dhr was reviewed for the hydrogel body sub-assembly which met all acceptance criteria.Raw material records were reviewed as well and all acceptance criteria was met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.All components and mix time were within tolerance.The complaint report indicates that samples were expected, however, no samples have been received.Production retains (5 sets) for lot # 605025x was evaluated and none of the five (5) retains evaluated exhibited any abnormalities.As a result of this investigation there is no manufacturing related root cause that could be determined.There are several important factors that can impact the adhesion of the product.Improper application of the electrode or applications without proper skin preparation can cause a failure to create inadequate 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 repo sitionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.To reduce and remove the incidents of storage induced adhesion issues please 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.Do not open package until ready for use.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.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.The environmental and handling condition in which the product was stored was not provided with the complaint.Based upon the investigative details and the root cause evaluation, no further corrective or preventative actions will be taken at this time.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the gel on a defibrillation electrode is not adhering to the skin, which would cause serious burns.

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer (Section G): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7441797
• MDR Text Key: 105907654
• Report Number: 1219103-2018-00005
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2018
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 605025X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1