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

Model Number	8900-0224-01
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated device failed self test using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

• 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: 50804517
• Report Number: 1218058-2026-00133
• Device Sequence Number: 8643779
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: (01)00847946016272(17)270402(10)1425H
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 1425H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• 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: 08/31/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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: Unknown