MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA, SINGLE

Model Number 8900-0225-01

Device Problems Arcing of Electrodes (2289); Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 09/24/2020

Event Type  Injury  

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 cardiovert a patient (age & gender unknown), sparks and smoke were seen coming from the attached electrode pads.After removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The severity of the burns sustained was not available.Please reference medwatch report number 1218058-2020-00089 for a similar report from the same customer.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference section b5 and h6:device code.Evaluation results: the electrodes were returned to zoll canada for evaluation.Evaluation of the electrodes found a heavy presence of hair on the foam adhesive of the electrodes, some discoloration and some creases.Information obtained from the customer also indicated that the patient's skin was not prepped prior to placing the electrode pads.Our electrode labeling indicates the importance of good placement on the patient and provides instructions for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of aring and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), sparks were seen coming from the attached electrode pads.After removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The severity of the burns sustained was not available.Please reference medwatch report number 1218058-2020-00089 for a similar report from the same customer.

• Brand Name: ELECTRODES, ONESTEP CPR AA, SINGLE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10819483
• MDR Text Key: 215616511
• Report Number: 1218058-2020-00087
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: 00847946016289
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/04/2022
• Device Model Number: 8900-0225-01
• Device Catalogue Number: 8900-0225-01
• Device Lot Number: 2320C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other