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

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 monitor a patient (age & gender unknown), the associated device displayed a "general electrode fault" message.Complainant indicated that the clinician obtained another set of onestep pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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 section d2.The electrodes were not returned for evaluation and no photographs were available for review.Based on the customer's description, the reported wire was likely the electrode shorting wire located between the electrodes within the packaging liner.The shorting wire is intended to provide continuity between the electrodes to support the device readiness self test and it's designed to remain attached to the liner when the electrodes are removed as intended.If the electrodes are not removed from the liner using the intended method in the pictoral instructions, the shorting wire may remain attached to the electrodes.Based on the available information, the reported observation is consistent with this condition.

• 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: 25056056
• Report Number: 1218058-2026-00058
• Device Sequence Number: 9427738
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: (01)00847946016272(17)270924(10)3925G
• 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): 04/14/2026

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: 3925G
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2025
• 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 Sex: Unknown