MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)

Model Number	8900-000219-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient less than one-year old (gender unknown), the electrode pads were damaged during removal from the packaging.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections b5, d1, d4 (model # and catalog #).Evaluation: the one step cpr pediatric electrode pads were returned to zoll medical corporation for evaluation.A visual inspection of the pads observed the back/sternum pad had seperated from the blue layer of the foam.This can occur if the electrode pads are removed incorrectly from the syrene liners as illustrated on the packaging by using the red tabs.The pads were scrapped after evaluation.The instructions for use for onestep cpr pediatric electrodes state "grasp the back/sternum electrode from the bottom red tab and peel from the plastic liner." analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient less than one-year old (gender unknown), the electrode pads were unable to adhere.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)
• Common Device Name: 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: 16829615
• Report Number: 1218058-2023-00094
• Device Sequence Number: 15235086
• Product Code: MKJ
• UDI-Device Identifier: 00847946001438
• UDI-Public: 00847946001438
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/06/2023

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: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/18/2023
• 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
• Patient Sex: Unknown