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

Model Number	8900-0221-01
Medical Device Problem Codes	Mechanical Problem (1384); Arcing of Electrodes (2289)
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 while attempting to cardiovert a patient (age & gender unknown), an arc was seen coming from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to 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.Evaluation: the onestep basic electrode pads were returned to zoll medical corporation.A visual inspection found that the apex pad was missing and appeared to have been physically removed.The foam was disassembled in an attempt to determine if the pads had been assembled correctly and there were no discrepancies found.The pad was scrapped.The customer's report of exposed wire was observed, however, it cannot be confirmed that it led to a spark/arc.The front pad was evaluated and confirmed a wire is exposed in the through hole.There are no signs of an arc or spark, overheating, or evidence that an arc occurred through the exposed shorting wire.Electrodes from retained samples of the same lot number 1420 were investigated.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.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), an arc was seen coming from the electrode pads and a wire had become exposed from the electrode pad.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 12261485
• Report Number: 1218058-2021-00105
• Device Sequence Number: 14349987
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: 00847946016241
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/20/2021

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: 04/01/2022
• Device Model Number: 8900-0221-01
• Device Catalogue Number: 8900-0221-01
• Device Lot Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown