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

Model Number	8900-0801-01
Medical Device Problem Code	Device Operational Issue (2914)
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), upon opening the electrode pad's packaging the wires were dislodged.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation and the customer's report was observed.The high voltage wire was observed to be detached consistent with the customer's report.Further investigation at the point of engagement showed evidence that the wire was crimped suggesting a force pulled it away from the connection.Review of the device history records showed that these pads passed the pull testing done during the manufacturing process prior to being released.Additionally, retained sample testing of the suspected lot number confirmed that there were no irregularities with this lot number (4416) that would have contributed to the wire being pulled away from the electrode.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP COMPLETE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 6666543
• Report Number: 1218058-2017-00063
• Device Sequence Number: 18843069
• Product Code: MKJ
• UDI-Device Identifier: 00847946016326
• UDI-Public: 00847946016326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2017

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: 8900-0801-01
• Device Catalogue Number: 8900-0801-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1