MAUDE Adverse Event Report: COVIDIEN CADENCE ZOLL PRECONNECT; ELECTRODE

Model Number 22770PC

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 08/07/2015

Event Type  Death  

Manufacturer Narrative

Submit date: 08/12/2015.An investigation is currently under way; 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 an electrode.The customer reported that on (b)(6) 2015, an electrode caught on fire while on a patient.The patient subsequently expired; however, the customer is not sure how much time passed between the electrode fire and the patient death.The patient was a (b)(6) male with a past medical history of cardiac disease.The nature of his cardiac disease and other past medical history is unknown.The patient may have originally presented with chest pain, but this is unclear as well.The customer is unaware of what any of the patient vital signs were at any point, but did state that they were concerned about his blood pressure.The customer was unsure of where the exact lead placement/position was, and the patients skin was not prepped with anything or in any way prior to affixing the electrodes.In total, the electrodes had been on the patient for eight hours.At several points within those eight hours, the patient went into ventricular fibrillation, and was defibrillated at 180 joules and then 200 joules.At about the eight hour mark of wearing the electrodes, the patient went into ventricular fibrillation again.He was shocked with 180 joules, and then again at 200 joules.Upon the 200 joule shock, one of the electrodes caught on fire.At this time, the patient had also been receiving an intravenous infusion of levophed.Unbeknownst to the healthcare team, the electrode fire had burned a hole in the intravenous tubing that was delivering the levophed to the patient.The customer is unaware of exactly how long the patient was not receiving the levophed.Once the health care team noticed the intravenous tubing had been burned, they replaced it with a new set and the patient continued his levophed infusion.After the fire was out, the health care team placed new pads on the patient and shocked the patient again.The customer reported that the patient came back, but then at some other unknown future point in time, went back into ventricular fibrillation and did not survive.The patient autopsy results are pending.The customer reported that there is a 1.5 inch burn hole on the electrode that had caught fire.The electrodes were not used for non-invasive cardiac pacing at any point during this incident.

Manufacturer Narrative

Multiple lot numbers were identified for this complaint therefore, a device history record (dhr) review was performed for lots 516313x, 507911x, 431114x, 510745x, 513426x, 505815x, and 512814x, and all acceptance criteria was met in regards to electrical testing and visual inspection prior to release.Samples were not provided, and were not expected, however photos were received for evaluation.Upon review of the photos, burn marks were present on the defibrillation electrode, as well as the presence of hair.Burn spots were also observed on the gel of the defibrillation electrode, which appears to be burnt hair.The photos revealed that the electrodes were properly constructed, and there did not appear to be any damage to the wire or electrode that would have resulted in this incident.Given the information provided in the complaint and its investigation, no root cause could be identified and may be attributed to manufacturing related deviations from the required specifications.The most likely root cause is the improper application of the electrodes to the patient.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, hair or another conductive material between the electrodes, the electricity will be more likely to flow across the chest rather than through it.This will result in ineffective defibrillation and an increased chance of sparks or fire.Electrode pads must come in direct contact with the skin.If the chest hair is so excessive as to prevent good adhesion of the electrode pad, the hair should be removed.Care should be taken to properly prepare the patient skin prior to electrode application and special consideration should be given to the electrodes and wires while working around a patient or moving a patient so that the electrodes are not damaged.

Event Description

To help the electrode make a good skin contact and to help reduce contact impedance the product labeling instructions and warnings should be followed as per the instructions for use (ifu); remove excess hair, clean and dry skin sites (during review of the provided pictures, it was observed that hair was present on the defibrillation electrodes).Do not use alcohol or tincture of benzoin.Position electrodes per the figures provided on the packaging.If possible, do not place electrodes on broken skin.Smooth the electrode from the center outward 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 and minimize potential patient skin burns.Replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.Do not use if electrode or pouch is damaged.Do not discharge hand-held paddles through these electrodes.Do not open package until immediately prior to use.Important: replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.Do not crush, fold, or store under heavy objects.Use separate ecg electrodes when performing noninvasive pacing.It is important that the operator be thoroughly familiar with the electrode operating instructions and warnings prior to use.Failure to comply with the product instructions for use or warnings may increase the likelihood of the incident of this nature.No corrective or preventive actions are necessary at this time.We will continue to trend this event for future occurrences as part of the complaint review process.

• Brand Name: CADENCE ZOLL PRECONNECT
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4995514
• MDR Text Key: 22723211
• Report Number: 1219103-2015-00006
• Device Sequence Number: 1
• Product Code: MLN
• 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: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22770PC
• Device Catalogue Number: 22770PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR