MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR, SINGLE, R SERIES

Model Number	8900-0223-01
Medical Device Problem Codes	Fire (1245); Arcing (2583)
Health Effect - Clinical Code	Necrosis (1971)
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 attempting to defibrillate a (b)(6)-year-old male patient, after the 6th shock an arc/fire was seen on the patient's chest from the electrode pads.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the associated defibrillator involved and the device performed to specification.The device was put through extensive testing including shock testing without duplicating any malfunction to the device.The electrode pads from the reported event were disposed of and not available for evaluation.Review of the device log confirmed the customer's report.The log showed a significant difference between patient and defib impedance measurements during the seventh shock.This is an indication of poor coupling between the patient and electrodes.It is important to note that the electrode instruction for use warns users that poor adherence of the electrodes could lead to the possibility of arcing and skin burns.Additionally, the r series operators guide warns users against using r series products in oxygen rich environments as it could cause an explosion.This report has been attributed to poor coupling of the electrode pads to the patient's skin.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12063139
• Report Number: 1218058-2021-00080
• Device Sequence Number: 11706113
• Product Code: MKJ
• UDI-Device Identifier: 00847946016265
• UDI-Public: 00847946016265
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 8900-0223-01
• Device Catalogue Number: 8900-0223-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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
• Patient Age: 60 YR