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

Model Number 8900-0224-01

Device Problems Improper or Incorrect Procedure or Method (2017); Arcing of Electrodes (2289); Difficult to Open or Remove Packaging Material (2922); Electrical Shorting (2926)

Patient Problem Death (1802)

Event Date 11/30/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while defibrillating a (b)(6) male patient, the electrodes were not opened correctly, resulting in the electrode shorting wire to be exposed to the patient's skin.When a discharge was given to the patient, an arc was seen.Complainant indicated that the wire was removed and treatment to the patient was continued.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The electrode pads were discarded subsequent to the patient event, therefore not available for evaluation.The customer had indicated that the electrodes were opened incorrectly.This resulted in a connection of the electrodes to the patient, with the shorting wire touching the patient's skin.The customer acknowledges that the pads were not opened correctly and recognizes they should be using the red tabs to open the packaging.Trend analysis was performed and no evidence of an increase in trend was found.

• 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: 5316319
• MDR Text Key: 34069074
• Report Number: 1218058-2015-00151
• 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
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Other Device ID Number: 00847946016272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death
• Patient Age: 70 YR