MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP COMPLETE ELECTRODE

Model Number	8900-000406-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the electrodes were slipping would not adhere to the patient's skin.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrode pads were not returned to zoll medical corporation; however, a zoll representative was onsite to visually inspect the electrode pads and no issues were found.The customer was contacted for return of the suspect product.The zoll representative was informed that the pads were disposed of and are not available for further evaluation.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP COMPLETE ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8169272
• Report Number: 1218058-2018-00106
• Device Sequence Number: 13890217
• Product Code: MKJ
• UDI-Device Identifier: 10847946021167
• UDI-Public: 10847946021167
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: 10/15/2020
• Device Model Number: 8900-000406-01
• Device Catalogue Number: 8900-000406-01
• Device Lot Number: 4218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1