MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ BISPHASIC MFE (1 PA); DEFIF/PACING ELECTRODE

Model Number	8900-2302-01
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
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 pace a male patient (age unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another set of pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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 d10.Zoll medical corporation evaluated the device (sn# (b)(6)) and the customer's report was not replicated during testing.The log and clinical files did not contain the reported event, as the data appears to have been overwritten during subsequent use.The returned pads were tested and passed continuity and pacing verification using a test device.The device was recertified and returned to the customer.The pads were scrapped after testing.No trend is associated with reports of this type.

• Brand Name: PRO PADZ BISPHASIC MFE (1 PA)
• Common Device Name: DEFIF/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket MA 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 23112104
• Report Number: 1218058-2025-00154
• Device Sequence Number: 9937376
• Product Code: MKJ
• UDI-Device Identifier: 00847946016418
• UDI-Public: (01)00847946016418(17)2605(10)3225
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/02/2025

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 Expiration Date: 05/05/2026
• Device Model Number: 8900-2302-01
• Device Lot Number: 3225
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: R SERIES. SN# (B)(6).
• Patient Sex: Male