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

Model Number	22550R
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the patient scheduled to have a cardioversion.When energy was delivered, a spark occurred on the cable from the defibrillator.The patient's skin was checked with no skin irritation or burn noted.The patient was cardioverted successfully during the procedure.Otherwise normal recovery and discontinue without issue.There was no harm to patient.
Additional Manufacturer Narrative
The device history records (dhrs) were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Quality assurance testing, performed based on a c=0 acceptable quality level (aql), 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.During production of the finished electrode there are two 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 damage 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.There were no samples received with this complaint therefore an examination of the reported condition was not possible.From a root cause analysis perspective, the investigation was unable to determine any possible manufacturing causes for the arcing.A review of the product specification and a risk assessment of the product was conducted to determine what possible causes could be and it was determined that if a manufacturing issue occurred, the damaged parts would not be sent to the customer as the issue is mitigated based on testing performed throughout the process.It is important to follow proper skin preparation prior to use, fabric fibers or chemical residue left of the skin could result in a spark.The product being used in an oxygen rich environment could also produce a spark during testing.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions are necessary.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 12354483
• Report Number: 1219103-2021-00335
• Device Sequence Number: 3726393
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 103492X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1