MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES

Model Number	8900-0221-01
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a male patient (age unknown), an arc was heard from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads and the customer's report was not replicated or confirmed.The pads were put through continuity testing that resulted in no findings.Visual inspection of the electrodes observed the wire connected to the anterior pad had melted adhesive stuck to the near edge of the pad.It was confirmed that the wire was not melted and that the material the customer believed as melted was excessive adhesive from the manufacturing process and not from a spark during the event.No evidence of sparking or burning was visually observed on either pad.It is important to mention, electrode labeling calls out the importance of good placement on the patient and provide instructions for proper electrode application technique.Poor adherence and /or air under the electrodes can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.No trend is associated with reports of this type'.

• Brand Name: ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 16526250
• Report Number: 1218058-2023-00045
• Device Sequence Number: 14776631
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: 00847946016241
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/17/2023

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 Expiration Date: 01/18/2025
• Device Model Number: 8900-0221-01
• Device Catalogue Number: 8900-0221-01
• Device Lot Number: 0223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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: Male