MAUDE Adverse Event Report: BIO DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE

Model Number	8900-0221-01
Medical Device Problem Code	Detachment Of Device Component (1104)
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 treating a patient (age & gender unknown) during transport, 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 lead wires with molded gasket, without the pair of electrodes, were returned to zoll medical corporation for evaluation.A continuity test was performed on the lead wires with no irregularities.We were unable to determine how the wire became detached from the electrode pads.Therefore, root cause could not be firmly established due to the missing electrode pads.It is important to mention no retainer evaluation could be performed since the lot number was unknown.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 6622180
• Report Number: 1218058-2017-00058
• Device Sequence Number: 10789449
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: 00847946016241
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 05/19/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1