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

Model Number 8900-000251-05

Device Problems Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/25/2023

Event Type  Injury  

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 an 88-year-old male patient, a spark was seen from the sternum electrode pad during the fourth discharge.After removing the electrode pads, second degree burns were found on the patient's skin.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.

Manufacturer Narrative

The onestep cpr pads were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The onestep cpr pads were put through extensive testing and successfully acquired a valid impedance and discharged appropriately.No anomalies were observed during visual inspection.Replacement pads were sent to the customer.No trend is associated with reports of this type.It is important to note that during defibrillation therapy, patients can experience burns and redness due to a high measured patient impedance.This could be for a variety of reasons including, but not limited to, skin preparation, electrode application, or poor coupling.

• 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: 16400908
• MDR Text Key: 309869072
• Report Number: 1218058-2023-00022
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/28/2024
• Device Model Number: 8900-000251-05
• Device Catalogue Number: 8900-000251-05
• Device Lot Number: 1822A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Male