MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE

Model Number 22770PC

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Injury (2348)

Event Date 02/19/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per the medwatch form received, no shock delivered when patient in vf (arrested).When hitting the shock button, no shock was given.After several attempts, the electrodes/leads were switched and they were able to deliver shock.

Manufacturer Narrative

The device history record (dhr) was reviewed for product 22770pc, lot # 617331x.All defib electrode and subassembly components met the required quality assurance tests and acceptance criteria to completely satisfy the manufacturing requirements per the product specification.Quality assurance testing included an array of electrical tests; dc offset voltage, ac small signal impedance, defibrillation recovery, noise, large signal impedance, simulated defib recovery, pacing impedance, pacing offset voltage, wave form duration and pacing energy loss were performed.In addition, the dhr for the defib gel body subassembly used in defib product 22770pc, lot 617331x was reviewed.The dhr for product sr00020 (defib gel body subassembly), lot 615517 and 615885, passed all acceptance criteria, including visuals and electricals.No abnormal processing conditions or testing results were identified.During production there are two different steps whereby the connector is plug into a receptacle (replicates plugging into therapy cord) that would cu ll out (reject the connector plug) any molding defects that would impair the connection.As part of the final assembly process of the defib electrode each defib electrode set is tested for continuity to ensure that the connector/gel body assembly is capable of conducting current, and that it demonstrates electrical continuity.Should this continuity test fail the product would be discarded.Lastly, prior to packaging the final defib electrode assembly the product is 100% visually inspected.This complaint is not confirmed 22770pc, lot 617331x passed dhr review, and the electrical tests on the production retains met the acceptance criteria.Evaluation of the defib electrodes which were alleged to not properly function were not supplied for evaluation.As a result of this investigation there is no manufacturing related root cause that could be determined.Potential root causes unrelated to the defib electrode manufacturing process are improper patient preparation, application of the electrode to the patient, handling and storage of electrodes and the defibrillator unit.To reduce and remove the incidents of storage induced issued 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 fro m 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.To reduce and remove the incidents of preparation induced issued please review the following instructions: 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.Firmly smooth the electrode from the center outwards to the edges with fingertips to ensure that there are no air pockets, and to ensure that the pad is securely adhered to the patient.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 therapy cord/defibrillator receptacle are free of debris and properly connected.This complaint is not confirmed; consequently, there are no further corrective or preventive actions required at this time.Further trending will be performed for similar reports.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDI-TRACE CADENCE
• 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: 6494509
• MDR Text Key: 72849959
• Report Number: 1219103-2017-05005
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Model Number: 22770PC
• Device Catalogue Number: 22770PC
• Device Lot Number: 617331X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other