MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE; ELECTRODES

Model Number	8900-000219-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 treat a patient (age & gender unknown), the electrodes would not adhere to the patient's skin.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Electrode pads were returned for evaluation.Both the returned electrode pads and the lot retained sample passed all testing and met manufacturing specification.It's noteworthy to mention that in communication with the customer as part of the investigation, we were told that the patient was diaphoretic and there was no preparation performed to the patient.It is important to note that during defibrillation therapy, patients can experience burns and redness due to a high measured patient impedance.This could be for a variety of reasons including, but not limited to, skin preparation, electrode application, or poor coupling.Zoll recommends that patients are cleaned and clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.This investigation was closed related to patient preparation prior to the application of the electrode pads.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE
• 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: 20171290
• Report Number: 1218058-2024-00086
• Device Sequence Number: 12460587
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: (01)00847946023348(17)260115(10)0324A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 08/20/2024

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: 01/15/2026
• Device Model Number: 8900-000219-01
• Device Lot Number: 0324A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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