MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 09/30/2020

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 defibrille a patient (age & gender unknown), an arc was heard coming from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).The pro padz electrodes lot 2020 were returned to zoll medical corporation opened and adhered together.Visual inspection found discoloration on the conductive plates and the gel dried out.The discoloration does not look like typical discoloration from a spark.Sparks are the cause of poor coupling; however, poor coupling cannot be confirmed.No evidence of sparking was found during testing.The electrode pads were scrapped as a result.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of sparking/arcing and skin burns.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), sparks were seen coming from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10680626
• MDR Text Key: 211517851
• Report Number: 1218058-2020-00079
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K960676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/13/2021
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1