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

Model Number	8900-0221-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown), the clinician observed that a wire had become dislodged from the electrode pad.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The anterior electrode was returned to zoll medical corporation; visual evaluation of the returned anterior electrode observed the frayed detached high voltage wire from the posterior electrode.Due to the posterior electrode not being returned for evaluation, we were unable to determine how the high voltage wire was detached.The customer was sent replacement electrode pads.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP BASIC, SINGLE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7146099
• Report Number: 1218058-2017-00144
• Device Sequence Number: 19057834
• 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
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 8900-0221-01
• Device Catalogue Number: 8900-0221-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1