MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	8900-0224-01
Medical Device Problem Codes	Material Separation (1562); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Justification for no udi, 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 attempting to treat a 66-year-old male patient, after multiple discharges the defib pads were changes, the patient's chest was wiped, pads were placed and a spark was emitted from the pads upon discharging.No burns were noted on the patient's skin.Complainant indicated the patient subsequently expired but was not a result of the malfunction.
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, d2, d4 lot #, d4 udi #, d4 expiration date, and h4 device manufacture date and h6 (medical device problem code.The returned onestep cpr complete electrodes were evaluated following a report of exposed metal that allegedly arced during defibrillation.Examination found the self-test shorting bar protruding from the electrode rather than adhered to the styrene, a condition that can occur if the package is not opened correctly.No exposed metal, electrical arcing, burn marks, or pad defects were identified, and electrical testing met specifications.Evaluation of retain samples from the same lot found no discrepancies.The reported issue could not be verified, and the investigation concluded the returned pads exhibited an isolated condition with no evidence of a lot-related manufacturing defect.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a 66-year-old male patient, after multiple discharges the pads were replaced, the patient's chest was wiped, and upon shock delivery a spark was observed from the defibrillation pads.It was also reported that the wire separated from the electrode.No burns were observed on the patient's skin.Complainant indicated the patient subsequently expired but was not a result of the malfuntion.

• Brand Name: ONESTEP
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 24496135
• Report Number: 1218058-2026-00024
• Device Sequence Number: 10685336
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: (01)00847946016272(17)271203(10)4925M
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/12/2026

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: 4925M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White