MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE

Model Number	8900-4006
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while cardioverting a patient (age & gender unknown), an arc was heard coming from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1218058-2019-00166 for a similar report from the same customer.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference sections d1, d4;model,d4;catalog, d4 lot; d4 expiration and d4;udi.The electrodes were received at zoll medical corporation for evaluation.Visual inspection of the electrodes found evidence of skin residue/debris and human hair confirming that the electrodes were used on a patient.Evidence of burn marks were also found on the rim of the conductor plates.Excess skin debris, hair and residue can interfere with the reading of the patient-pad resistance and can lead to an increased resistance measurement which in turn will cause the device to deliver a higher current.Poor coupling of the electrode pads to the patient's skin has the possibility to lead to instances of arcing.This report has been attributed to poor coupling of the electrode pads to the patient's skin.It should be noted that the utilization of therapy electrode does not guarantee a burn will not occur and burns from defibrillation are an expected risk.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9444391
• Report Number: 1218058-2019-00167
• Device Sequence Number: 2209612
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: Other
• Device Expiration Date: 12/02/2020
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 4919A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1