MAUDE Adverse Event Report: COVIDIEN CADENCE HEARTSTREAM ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22660R-

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.¿as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.¿if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the cadence defib pad was unable to deliver a shock to a patient requiring defibrillation during open heart surgery.A shock was able to be generated using internal paddles and the patient recovered normally.

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, replicating plugging into therapy cord, that would cull out any molding defects 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.For the reported lot, sets were made between 10/08/20 and 10/09/20.There were no samples received with this complaint therefore an examination of the reported issue could not be made.As part of the dhr review, retain samples were pulled and tested for electrical's, shocking, pacing and pull testing.All testing passed with no abnormalities noted.A review of the process failure mode effects analysis (pfmea) and a risk assessment of the product was done to determine possible causes related to the manufacture of the product.If the electrode was not built correctly it would be noticed based on the testing performed throughout the process.There are several important factors outside of the manufacturing process that can impact the adhesion of the product resulting in issues.Improper application of the electrode or applications without proper skin preparation can cause a failure to adhere properly resulting in reading/tracing issues.Issues may arise if hair is on the foam adhesive and gel body.Movement of the patient after application of the electrodes should therefore be minimized.Electrodes should be placed on relaxed skin (not stretched or contracted) if possible.Third, electrodes placed on a patient¿s back can be peeled off when the patient is slid from bed to another.Electrodes should therefore be placed after the patient transfer if possible.Finally, the electrode can dry out as a result of the package being left open for an extended period of time.It is also important that the electrodes be connected to the patient before connection to the defibrillator.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 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 action is required at this time.The manufacturing site will continue to trend for future occurrences as part of the complaint review process.

• Brand Name: CADENCE HEARTSTREAM ADULT RTS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11202222
• MDR Text Key: 227782378
• Report Number: 1219103-2021-00313
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022349
• UDI-Public: 20884527022349
• 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
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22660R-
• Device Catalogue Number: 22660R-
• Device Lot Number: 026908X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Patient Sequence Number: 1