MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ; DEFIB/PACING ELECTRODE

Model Number	8900-4004
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged while attempting to treat a 63-year-old female patient weight 211 pounds, the device was unable to obtain an ecg signal via electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrodes were not returned to zoll medical corporation for evaluation.Instead, zoll evaluated retained samples from the same lot (5025) of stat-padz electrodes (p/n: 8900-4003).Visual inspection, continuity checks, and electrical testing including defibrillation and impedance testing did not replicate or confirm the customer's report.The pads were confirmed to be built to specification and functioned as intended.No trend is associated with reports of this type.It is noteworthy to mention, the x series operator's guide states: preparing the patient for electrode application: the proper application of electrodes is essential for high quality ecg monitoring.Good contact between the electrodes and skin minimizes motion artifact and signal interference.Before applying the electrodes, prepare the patient's skin, as necessary, shave or clip off excess hair at electrode site, clean oily skin with an alcohol pad, and rub site briskly to dry.

• Brand Name: STAT PADZ
• Common Device Name: DEFIB/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: 24345149
• Report Number: 1218058-2026-00017
• Device Sequence Number: 18560402
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: (01)00847946016456(17)271210(10)5025
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P160015
• 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): 01/27/2026

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: 8900-4004
• Device Lot Number: 5025
• Was Device Available for Evaluation?: No
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2025
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Race: White