MAUDE Adverse Event Report: BIO-DETEK INCORPORATED; UNKNOWN

Lot Number	4525
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2026
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to treat a 3-year-old patient (gender unknown) post drowning, the electrode pads would not adhere to the patient's skin.A 2nd set of electrode pads were used with the same results.The lot numbers of the pads are lot: 4525 and lot: 1825b.Complainant indicated that the patient subsequently expired.Please reference medwatch 1218058-2026-00101 for pads lot: 1825b.
Additional Manufacturer Narrative
This device was manufactured but not domestically distributed; it is only distributed in the intended geography.There is no existing udi regulation.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

• Brand Name: UNK
• Common Device Name: UNKNOWN
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; +1(401)729-1400
• MDR Report Key: 25894487
• Report Number: 1218058-2026-00102
• Device Sequence Number: 10124812
• Product Code: MKJ
• UDI-Device Identifier: 10847946016316
• UDI-Public: 10847946016316
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Lot Number: 4525
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 3 YR
• Patient Sex: Unknown