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

Model Number	8900-0224-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has a udi; some information was not provided and is unknown; therefore, a complete udi cannot be provided.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 defibrillating a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient.Complainant indicated that the patient suffered burns.No information was available on the degree of burns.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.Device, electrodes, and event data were not returned, and no additional information was obtained despite follow up attempts.The event could not be substantiated and burn severity is unknown.Sparking/arcing during defibrillation may occur due to high patient impedance associated with poor electrode coupling, improper application, or inadequate skin preparation, as noted in the instruction for use (ifu).The claim will be close as no product returned and will be reopened if the product is received.

• Brand Name: ONESTEP
• 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: 24815567
• Report Number: 1218058-2026-00050
• Device Sequence Number: 18563561
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• 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): 03/19/2026

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: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown