MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP COMPLETE ELECTRODE

Model Number 8900-0224-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Vitrectomy (2643)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during a routine shift check by a clinician, the associated device displayed a "poor pad contact" message using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The electrodes were returned for evaluation; the malfunction was duplicated during visual evaluation.The malfunction was attributed to a disconnected jumper wire (self test wire) on the electrode pad.This type of failure does not disable the electrode from delivering therapy when attached to a defibrillator.This is a malfunction which only impacts self-test of the electrode with the defibrillator.This type of malfunction does not pose any clinical impact and does not meet our guidelines for reportability.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP COMPLETE ELECTRODE
• 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: 7575762
• MDR Text Key: 110357241
• Report Number: 1218058-2018-00043
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/17/2019
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 3817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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