MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	8900-4004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has an udi; some information was not provided and is unknown; therefore, a complete udi cannot be provided.Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while defibrillating a patient (age & gender unknown); after removing the electrode pads, a skin blister/tear was found on the patient.Complainant indicated that the patient sustained a sternal skin tear.No further information was available.

• Brand Name: STAT PADZ
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 25718134
• Report Number: 1218058-2026-00091
• Device Sequence Number: 10618972
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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 Model Number: 8900-4004
• Date Returned to Manufacturer: 06/27/2026
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown