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

Model Number 22550PC

Device Problems Signal Artifact/Noise (1036); Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7/13/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The electrode is not working during a planned procedure (cardioversion).

Manufacturer Narrative

Submission date: 09/12/2018 an investigation was performed for the reported customer complaint: ¿customer reports: the electrode is not working during a planned procedure (cardioversion).¿ a review of the device history record (dhr) for lot no.727730x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.In addition, the dhrs for the defib gel body subassembly used in the production of this lot were reviewed.The dhrs for the defib gel body subassembly (lots 721215 & 727234) passed all acceptance criteria, including visuals and electrical testing.No abnormal processing conditions or testing results were identified.All defib electrode and subassembly components must pass quality assurance testing and meet acceptance criteria to completely satisfy the manufacturing requirements per the product specification.The testing consists of an array of electrical tests which include: 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.During production there are two (2) different steps whereby the connector is plug into a receptacle (replicates plugging into therapy cord) that would cull 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.The customer returned sixteen (16) defib electrode sets for evaluation.Eleven (11) electrodes were in the original sealed pouches & poly-bags, four (4) were in original sealed pouches & no poly-bags, and one (1) opened pouch, used electrode was received.The used electrode set was in a condition whereby each electrode pad was folded over onto itself (were not applied to carrier liner).The electrode set was somewhat dried out due to being in an unsealed pouch.It should also be noted that two (2) of the electrodes set pouches were in poor condition, including the electrode set that had been placed on the patient.A therapy cable fit test was performed on the returned electrodes.The connectors plugged in with ease, with no issues observed on all 16 defib electrode sets.The defib electrode sets were visually inspected.All components were present and were constructed per the product specifications.The gel bodies were inspected for silver print.The printed silver pattern on the conductive gel bodies met the acceptance criteria.Ten (10) of the electrodes, including the used electrode set, were subjected to a full array of tests in accordance with internal inspection protocol for defib properties (included shocking & pacing).All ten (10) of the electrode sets were recognized by the defibrillator unit.During the test, the wires were manipulated throughout the process.The defib electrode set did not cut out.The test results were within the acceptance criteria to completely satisfy the manufacturing requirements per the product specification, except for the electrode set that was dried out (used on patient & not in sealed pouch).The impedance values were elevated.However, this is not unusual (but expected) for electrodes that are not sealed within a protective pouch, as well as being placed on a patient.The ten (10) sets were also subjected to dielectric withstand testing to confirm the wires had not been comprised (damage to insulation).No issues were observed.Lastly, the remaining six (6) defib electrodes were visually inspected.All components were present and constructed per product specifications.The gel bodies were inspected for silver print.The printed silver pattern on the conductive gel bodies met the acceptance criteria.A therapy cable fit test was performed on the six (6) electrodes.The connectors plugged in with ease, no issues observed.All six (6) of the electrode sets were recognized by the defibrillator unit.While the electrodes were plugged into the defibrillator unit the wires were manipulated, defib electrodes did not cut out.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.The following instructions will reduce and/or remove incidents of preparation induced issues: 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.To reduce and remove the incidents of storage induced 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.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 (evaluation of the returned product observed pouches in poor condition).Potential root causes unrelated to the defib electrode manufacturing process include improper patient preparation, application of the electrode to the patient, handling & storage of electrodes and the defibrillator unit.As a result of this investigation, there is no manufacturing related cause that could be determined.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.Additionally, this complaint will be shared with the defib focus factory to promote awareness.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 7685681
• MDR Text Key: 114335742
• Report Number: 1219103-2018-00011
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 10884527022328
• UDI-Public: 10884527022328
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2019
• Device Model Number: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 727730X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1