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

Model Number	8900-0222-01
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during a routine shift check by a clinician, the associated defibrillator displayed a "check pads" message using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The actual electrodes from the event were not available for evaluation.Instead, electrodes from retained samples of the same lot number 0918 were evaluated.Five retained pairs were subjected to all electrical testing, impedance testing, 30j self tests and code readiness testing with no discrepancies found.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP PACING
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7776774
• Report Number: 1218058-2018-00063
• Device Sequence Number: 11063874
• Product Code: MKJ
• UDI-Device Identifier: 00847946016258
• UDI-Public: 00847946016258
• 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): 07/24/2018

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: 02/26/2020
• Device Model Number: 8900-0222-01
• Device Catalogue Number: 8900-0222-01
• Device Lot Number: 0918
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1