MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODE ONESTEP CPR A/A GC, SINGLE

Model Number 8900-000251-05

Device Problems Smoking (1585); Arcing of Electrodes (2289); Noise, Audible (3273)

Patient Problem Necrosis (1971)

Event Date 03/02/2023

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 attempting to defibrillate a 62-year-old male patient, a loud pop noise was heard on delivery of the third shock, along with a white flash and smoke were seen from the electrode pads.The pads were then removed to replace and upon removal, a burn of an unknown degree was seen on the patient's chest.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Manufacturer Narrative

The electrodes were returned to zoll medical united kingdom for evaluation.Evaluation of the electrodes revealed that there was an excessive amount of hair attached to the gel.The electrodes passed continuity testing.The logs from the event were not provided.Based on the customer's description and observed excessive hair on the electrode, this claim will be closed as poor coupling between patient and electrode due to poor patient preparation.R series operator's guide, patient safety, states: "excessive body hair or wet, diaphoretic skin can inhibit electrode coupling to the skin.Clip excess hair and dry any moisture from the area where an electrode is to be attached." analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODE ONESTEP CPR A/A GC, SINGLE
• 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: 16526424
• MDR Text Key: 311121335
• Report Number: 1218058-2023-00056
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-000251-05
• Device Catalogue Number: 8900-000251-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• 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: 62 YR
• Patient Sex: Male