MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE; ELECTRODE, DEFIBRILLATION

Model Number	8900-2101-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a (b)(6) year-old male patient, after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained second degree burns.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, the device log was provided for review.Review of the device log showed a large difference between recorded defib impedance and patient impedance.This is often an indication of poor coupling to the patient.However, without receipt of the electrode pads, this cannot be confirmed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE
• Common Device Name: ELECTRODE, DEFIBRILLATION
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12509352
• Report Number: 1218058-2021-00120
• Device Sequence Number: 3787679
• Product Code: MKJ
• UDI-Device Identifier: 00847946016395
• UDI-Public: 00847946016395
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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
• Operator of Device: Other
• Device Expiration Date: 09/26/2022
• Device Model Number: 8900-2101-01
• Device Catalogue Number: 8900-2101-01
• Device Lot Number: 1321A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR