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

Model Number	8900-0221-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a male patient (age unknown), the staff stated the posterior pad had no gel on it.The gel was stuck to the packaging.Complainant indicated that the clinician obtained another set of 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
This supplemental report is reporting the evaluation of the device and correcting information submitted on the initial report.Please reference section d2.The product was returned to zoll medical corporation for evaluation.The customer reported that the posterior onestep basic electrode pad appeared to have no gel, with the gel adhered to the inside of the packaging.Evaluation of the returned electrodes (lot #2825a) confirmed that the styrene liners were not present and the posterior pad gel was bunched in the center of the pad and adhered to the packaging.Visual inspection found no damage to the pad assembly.Because the electrodes were returned in used condition, the cause and timing of the gel displacement could not be determined.Continuity testing from the connector to the tins passed successfully, confirming electrical integrity.The electrodes were subsequently scrapped following evaluation.Analysis of reports of this type has not identified an increase in trend.

• 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 ; +1(401)729-1400
• MDR Report Key: 25047505
• Report Number: 1218058-2026-00060
• Device Sequence Number: 13206802
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: (01)00847946016241(17)270712(10)2825A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: 8900-0221-01
• Device Lot Number: 2825A
• Date Returned to Manufacturer: 04/22/2026
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/23/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 Sex: Male