MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR AA; ELECTRODE

Model Number	8900-0225-01
Medical Device Problem Codes	Sparking (2595); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Low Blood Pressure/ Hypotension (1914)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a 50-year-old male patient, sparks were emitted from the electrodes, after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient suffered burns.No information was available on the degree of burns.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d4 lot # and expiration date updated and h4 manufacturing date updated.The onestep cpr electrodes lot 3624c were returned to zoll medical corporation for evaluation.Upon inspection, it was observed that the apex and sternum both had strands of hair covering various pohttps://emdr.Fda.Gov/emdr/formredaction/d11.Jsf#rtions of the foam with no irregularities of note.Review of the material report log and dhr for the lot found no issues with the pads from lot 3624c.It is important to note that during cardioversion therapy, patients can experience burns and redness due to a high measured patient impedance.This could be for a variety of reasons including, but not limited to, skin preparation, electrode application, or poor coupling.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP CPR AA
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 20854879
• Report Number: 1218058-2024-00109
• Device Sequence Number: 8776236
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: 00847946016289
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/04/2024

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 Expiration Date: 09/03/2026
• Device Model Number: 8900-0225-01
• Device Lot Number: 3624C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male