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

Model Number 8900-0224-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the associated defibrillator was unable to obtain an ecg signal using these electrode pads.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrodes were returned to zoll for evaluation; visual examination found the high voltage wire was disconnected.Further visual examination found that there was evidence that the wire had been connected appropriately during manufacturing.A review of the retained sample from two separate lots was performed.There were no abnormalities found.The event electrodes were scrapped subsequent to testing.Analysis for reports of this type has not identified an increase in trend.

Manufacturer Narrative

This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.Please reference sections the electrodes were returned to zoll medical corporation; the reported malfunction was observed and determined to be an open wire on the high voltage wire.The high voltage wire was disconnected, severed, at the tin plate crimp ring.The cause of the wire becoming disconnected is believed to be due to an inadvertent external pulling source.Our records show that the electrodes passed testing before its release.The electrodes were scrapped and the customer received a replacement.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: 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: 6323834
• MDR Text Key: 67486862
• Report Number: 1218058-2017-00010
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/11/2018
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 2416
• Other Device ID Number: 00847946016272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 80