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

Model Number	8900-4004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 attempting to cardiovert a patient (age & gender unknown), the attached electrode pads came off the patient's skin after one cardioversion.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated stat-padz (p/n: 8900-4003) from lot 1124c and the customer's report was not replicated or confirmed.The electrodes showed proper assembly, with gel residue observed surrounding the tin on the back pad.The reported issue describes the gel detaching after one cardioversion.If the pads were removed or repositioned on the patient, it is possible that the gel remained adhered to the patient's skin.The instructions for use (ifu) for the stat-padz (aw-r1345-112 rev j) advise that if repositioning is necessary, replacing the electrodes is recommended.No trend is associated with reports of this type.

• Brand Name: STAT PADZ
• Common Device Name: DEFIB/PACING ELECTRODE
• 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: 20200206
• Report Number: 1218058-2024-00090
• Device Sequence Number: 7649747
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: (01)00847946016456(17)260312(10)1124C
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 03/12/2026
• Device Model Number: 8900-4004
• Device Lot Number: 1124C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 Sex: Unknown