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

Model Number 8900-0224-01

Device Problem Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during a cardioversion to a pt, an arc was seen from the electrode pads when the associated defibrillator discharged.Complainant indicated that there was no pt involvement in the reported malfunction.

Manufacturer Narrative

The customer has indicated that the event electrodes have been discarded and are not available for evaluation.The complainant indicated that the patient at the time of the cardioversion was somewhat hairy and was not shaved prior to defibrillation.The lot number of the suspect pads was not available, so a review of the retained sample was not performed.This investigation was closed as no sample returned for evaluation.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 5048870
• MDR Text Key: 24954844
• Report Number: 1218058-2015-00051
• 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
• Source Type: unknown
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01

Other Device ID Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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 Age: 56 YR