MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, MFE, PRO-PADZ, BIPHASIC; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 9600-0127

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

Patient Problem Burn(s) (1757)

Event Date 06/24/2021

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), after removing the electrode pads, burns were found on the patient's skin and an spark was seen from the electrode pads.Complainant indicated that the patient subsequently sustained a burn.The customer was unable to provide information on the degree of the burn.

Manufacturer Narrative

The device was returned to zoll medical corporation and there was no indication of a device malfunction.The original electrodes were misplaced and were unavailable for testing.The part number for these pads did not have the lot number provided by the customer, built.(i.E.No lot number 1521b were built for pn 9600-0127).The device passed all testing including discharging, a defib cycle, bench handling, and defib impedance using test electrodes without duplicating the report.The logs were not saved and were unavailable for review.The device was recertified and returned to the customer.Burns and sparking are often caused when there is poor coupling between the patient and the applied defibrillation electrodes.Poor coupling can be caused by many factors including but not limited to: electrode placement and/or application (which can lead to excessive air trapped between the skin and gel), poor patient preparation, patient history, skin condition, old dry gel, etc.The cause of the poor coupling cannot be firmly established.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, MFE, PRO-PADZ, BIPHASIC
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: 12192168
• MDR Text Key: 262431256
• Report Number: 1218058-2021-00094
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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
• Device Operator: Other
• Device Expiration Date: 01/07/2022
• Device Model Number: 9600-0127
• Device Catalogue Number: 9600-0127
• Device Lot Number: 1521B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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