MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES

Model Number	8900-0402
Medical Device Problem Codes	Arcing of Electrodes (2289); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Death (1802); No Information (3190)
Date of Event	02/07/2020
Type of Reportable Event	Death
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 on the fourth defibrillation attempt on a patient (age & gender unknown), an arc was heard from the electrode pads.After removing the electrode pads, burns were found on the patient.Complainant indicated that the clinician obtained another device set of electrode pads and other defibrillations took place, to continue treating the patient.The complainant did not indicate the severity of the burns sustained by the patient.
Event or Problem Description
Complainant alleged that while on the fourth defibrillation attempt on a patient (age & gender unknown), an arc was heard from the electrode pads.After removing the electrode pads, burns were found on the patient.Complainant indicated that the clinician obtained another device set of electrode pads and other defibrillations took place, to continue treating the patient.The complainant that the patient subsequently expired.
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 b2, b5, h1 and h6;patient code.Evaluation results: the device was not returned, instead the suspect electrode pads were received for evaluation.The electrodes were adhered together with the cpr puck in between the pads.The pads were separated and visually inspected.There was evidence of arcing on the outer edge of the sternum pad.The energy concentration observed on the pads showed that the energy took the path of least resistance.Which indicates that there was poor coupling of the electrode pads to the patient's skin (air).This report has been closed as poor coupling (continuity).Unable to determine if the patient's clinical condition contributed to the coupling of the electrodes.Analysis of reports of this type has not identified an increase in trend.

• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9930483
• Report Number: 1218058-2020-00029
• Device Sequence Number: 11371973
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other