MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, PRO-PADZ ADULT RADIOLUCENT MULTIFUNCTI

Model Number 9600-0037

Device Problems Accessory Incompatible (1004); Sparking (2595)

Patient Problem Burn(s) (1757)

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 treat a patient (age & gender unknown), a spark was seen from the electrode pads and after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient sustained a burn; however were unable to provide what degree the burn was.

Manufacturer Narrative

The customer was contacted for return of the suspect product and indicated the electrode pads would be returned.However, to date the electrode pads, device or clinical data have not been returned for evaluation.

• Brand Name: ELECTRODES, PRO-PADZ ADULT RADIOLUCENT MULTIFUNCTI
• 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: 12434220
• MDR Text Key: 270155069
• Report Number: 1218058-2021-00117
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/08/2022
• Device Model Number: 9600-0037
• Device Catalogue Number: 9600-0037
• Device Lot Number: 1521D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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