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

Model Number	8900-0224-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
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 during functional testing, the associated defibrillator failed to discharge using these attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
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 section d1, d4, and h4.Evaluation: the onestep complete electrode pads were returned to zoll medical canada.The customer's report was verified and attributed to the electrodes.Electrodes from retained samples of the same lot number 0821d were investigated.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Replacement set of electrode pads were sent to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12234935
• Report Number: 1218058-2021-00096
• Device Sequence Number: 3681686
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: 00847946016241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 02/19/2023
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 0821D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1