MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC; ELECTRODE

Model Number	8900-000219-01
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
Additional Manufacturer Narrative
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 patient (age & gender unknown), the associated defibrillator was unable to detect the attached electrodes.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The pads were returned to zoll medical corporation for evaluation.The pads were received unopened and in good condition and were successfully recognized by a known good device during initial testing.Further evaluation identified an intermittent fault within the internal shorting wire assembly when the pads were handled or stressed, which can trigger "check pads" messages and give the appearance that the device is not recognizing the pads.The pads were found to have a slightly disconnected self-test wire between the electrodes, resulting in elevated impedance that could prevent self-test initiation.The intermittent condition is consistent with the reported symptoms.The electrodes were scrapped as a precaution.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP PEDIATRIC
• Common Device Name: ELECTRODE
• 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: 24605103
• Report Number: 1218058-2026-00033
• Device Sequence Number: 21425638
• Product Code: MKJ
• UDI-Device Identifier: 00847946016197
• UDI-Public: (01)00847946016197(17)271217(10)5125
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/25/2026

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: 8900-000219-01
• Device Lot Number: 5125
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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