MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

Model Number 8900-0402

Device Problem Arcing of Electrodes (2289)

Patient Problem Cardiac Arrest (1762)

Event Type  malfunction  

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 defibrillating an 87-year-old female patient in cardiac arrest, an arc was heard from the electrode pads.Complainant indicated that the clinician obtained another set of defib pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 18806587
• MDR Text Key: 336751314
• Report Number: 1218058-2024-00017
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Device Lot Number: 3523E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2023
• 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: 87 YR
• Patient Sex: Female