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

Model Number 22550PC

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported that the patient was in fibrillation following the cec, therefore defibrillation was necessary.The nurse attempted to defibrillate the patient with the external pads, without success.They used internal paddles to defibrillate the patient.The patient did not suffer from the incident as they quickly used the internal paddles.The emergency internal defibrillation resolved the issue.Additional information provided on july 26, 2021 stated that the procedures being performed were x2 coronary artery bypass grafting (cabg) and 2x mammary coronary bypass surgery.The thorax was already open when the internal paddles were used because the surgery was taking place.Cec refers to extracorporeal circulation.There was a three minute delay in defibrillation.There was no other medical treatment or intervention required.The patient's current status is normal.Additional information provided on july 28, 2021 stated that the machine did not detect the pads, therefor the pads could not deliver the shock.

Manufacturer Narrative

Section b5 has been updated to include: additional information provided on july 29, 2021 stated that the defibrillator model used was a lifepak 15 from stryker.

Event Description

The customer reported that the patient was in fibrillation following the cec, therefore defibrillation was necessary.The nurse attempted to defibrillate the patient with the external pads, without success.They used internal paddles to defibrillate the patient.The patient did not suffer from the incident as they quickly used the internal paddles.The emergency internal defibrillation resolved the issue.Additional information provided on july 26, 2021 stated that the procedures being performed were x2 coronary artery bypass grafting (cabg) and 2x mammary coronary bypass surgery.The thorax was already open when the internal paddles were used because the surgery was taking place.Cec refers to extracorporeal circulation.There was a three minute delay in defibrillation.There was no other medical treatment or intervention required.The patient's current status is normal.Additional information provided on july 28, 2021 stated that the machine did not detect the pads, therefor the pads could not deliver the shock.Additional information provided on july 29, 2021 stated that the defibrillator model used was a lifepak 15 from stryker.

Manufacturer Narrative

Section b5 has been updated to include: additional information provided on august 19, 2021 stated that the facility has done tests on the lifepak15 gbm 2007776 defibrillator according to the performance inspection procedures of the technical manual.They did not find any abnormalities given the risk of a similar problem occurring.They will send the lifepak15 defibrillator to the manufacturer for further testing.

Event Description

The customer reported that the patient was in fibrillation following the cec, therefore defibrillation was necessary.The nurse attempted to defibrillate the patient with the external pads, without success.They used internal paddles to defibrillate the patient.The patient did not suffer from the incident as they quickly used the internal paddles.The emergency internal defibrillation resolved the issue.Additional information provided on (b)(6) 2021 stated that the procedures being performed were x2 coronary artery bypass grafting (cabg) and 2x mammary coronary bypass surgery.The thorax was already open when the internal paddles were used because the surgery was taking place.Cec refers to extracorporeal circulation.There was a three minute delay in defibrillation.There was no other medical treatment or intervention required.The patient's current status is normal.Additional information provided on july 28, 2021 stated that the machine did not detect the pads, therefor the pads could not deliver the shock.Additional information provided on july 29, 2021 stated that the defibrillator model used was a lifepak 15 from stryker.Additional information provided on august 19, 2021 stated that the facility has done tests on the lifepak15 gbm 2007776 defibrillator according to the performance inspection procedures of the technical manual.They did not find any abnormalities given the risk of a similar problem occurring.They will send the lifepak15 defibrillator to the manufacturer for further testing.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Quality assurance testing included an array of electrical tests.During production of the finished electrode there are two different steps whereby the connector is plug into a receptacle that would cull out any molding issues that would impair the connection.As part of the final assembly process of the defib electrode each defib wire set is tested for continuity to ensure that the connector assembly can conduct current, and that it demonstrates electrical continuity.Should this continuity test fail, the product would be discarded.Finished goods wire testing is performed to ensure the finished product is working correctly.Lastly, prior to packaging the final defib electrode assembly, the product is 100% visually inspected.The sample for the case was received as one set of electrodes.A visual inspection showed the electrodes are fully stuck together and were destroyed when the attempt was made to pull them apart.There is, what appears to be, tape on the heart foam.There is a pink substance in a splash pattern across the heart foam.The sternum foam print is severely faded indicating it encountered a substance that wiped the print off.There is also a piece of, what appears to be, plastic stuck between the electrodes.The plug has been cut from the electrode set.Due to the plug being cut off, it was not possible to perform any electrical testing on the product or to inspect the plug for defects.Retain samples were pulled and tested using all the same criteria as normal production.All electrical testing was within the acceptable tolerances on the retained samples.From a root cause analysis perspective, the investigation was unable to verify any causes related to the manufacturing process.There are several important factors outside of the manufacturing process that can impact the adhesion of the product resulting in reading/tracing issues.Improper application of the electrode or applications without proper skin preparation can cause a failure to adhere properly resulting in reading/tracing issues.Electrode pads must come in direct contact with the skin (no air pockets).If the chest hair is so excessive as to prevent good adhesion of the electrode pad, the hair should be removed.The instructions for use (ifu) state to remove excess hair, and to clean and dry skin sites.The ifu also stated not to use alcohol or tincture of benzoin.The electrode should be smoothed 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 and should be replaced with new electrodes if repositioning is required.The package should not be opened until immediately prior to use.It is important to replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.It is also important that the electrodes be connected to the patient (or test analyzer unit) before connection to the defibrillator.The defibrillator may produce a ¿check electrodes¿ warning if the electrodes are plugged in before they are connected to a patient.If the defib connector is not properly plugged into the patient therapy cord or if the therapy cord is damaged or the plug is worn (poor connection) the clinician could experience issues as described in the complaint.Given the information provided in the complaint and its investigation, no root cause could be identified related to manufacturing issues or deviations from the required specifications.From a corrective and preventative action standpoint, no further action is required at this time.The manufacturing site will continue to trend the reported condition for future occurrences as part of the complaint review process.This complaint will be used for tracking and trending purposes.

• Brand Name: CADENCE PHYSIO PRECONNECT
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 12247867
• MDR Text Key: 264352538
• Report Number: 1219103-2021-00333
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022325
• UDI-Public: 20884527022325
• 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,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 114746X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 84