MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ; ELECTRODES

Model Number	8900-4004
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while pacing a 60-year-old male patient, the electrode pads were damaged during opening/removal of packaging.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
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The stat-padz electrodes lot #4425 were returned to zoll medical corporation in opened original packaging.Visual inspection found that the high-voltage wires for both pads were disconnected from the ring and socket connections.Further examination showed the wires had been pulled out from the connection points, and tearing was observed in the surrounding foam.A review of the device history record (dhr) confirmed that final release pull testing was performed on 13 samples (26 wires), and all met the minimum requirement.In addition, all pads undergo continuity testing prior to packaging.Based on these results, the damage would not have been present prior to packaging and is not consistent with normal use.The investigaion concluded the customer report was due to user mishandling.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: STAT PADZ
• 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: 24162050
• Report Number: 1218058-2026-00008
• Device Sequence Number: 21082803
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: (01)00847946016456(17)271029(10)4425
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/06/2026

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: 4425
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male