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

Model Number	8900-0224-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to treat an 81-year-old patient (gender unknown), that a wire had become dislodged from the electrode pad.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Medwatch number: (b)(4).
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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 b5, b6, b7, and d1 brand name.Zoll received a report that during pacing, a ground wire appeared to remain attached to the defibrillation pads while on the patient; however, the wire was removed without harm to the patient or user.The picture suggests the shorting wire remained attached to the electrodes when removed from the packaging and applied to the patient.Investigation determined that the component was not a grounding wire but a shorting connector designed to enable device readiness testing while the pads are packaged.This connector is intended to automatically disconnect and remain within the packaging liner upon pad removal for patient use.The pads were discarded and not returned, preventing physical evaluation; therefore, the exact cause of the connector remaining attached could not be determined.Available information suggests the condition may be related to pad removal technique, including force applied and location of pull, which may affect retention of the connector within the liner.Regardless, the electrode pads are capable of delivering therapy with a potential risk of a minor burn during therapy if the exposed non-insulated part of the wire comes into contact with the patient.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged while attempting to treat an 81-year-old patient (gender unknown), a ground wire appeared to remain attached to the defibrillation pads while on the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Medwatch number:(b)(4).

• 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: 24405418
• Report Number: 1218058-2026-00025
• Device Sequence Number: 21269390
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: (01)00847946016272(17)270618(10)252B
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/02/2026

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 Model Number: 8900-0224-01
• Device Lot Number: 2525B
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2025
• 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
• Patient Age: 81 YR
• Patient Sex: Unknown