MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR AA; ELECTRODES

Model Number	8900-0225-01
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 that during biomed testing, the associated device failed the self-test using these onestep pads.Complainant indicated that there was no patient involvement in 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
The customer was contacted for return of the suspect electrodes.The electrodes have not been returned to zoll for evaluation.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.During the investigation it was noted that the reported incident would not pass the readiness test or the manual 30j test.Based on investigation testing the pads were confirmed to be defective (shorting bar open).The pads (8900-0225-01 lot 1025) were scrapped.The customer was sent replacement pads.No emerging trend based on similar reports.

• Brand Name: ONESTEP CPR AA
• Common Device Name: ELECTRODES
• 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: 23680187
• Report Number: 1218058-2025-00188
• Device Sequence Number: 15879968
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: (01)00847946016289(17)270305(10)1025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/14/2025

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: 8900-0225-01
• Device Lot Number: 1025
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/24/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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