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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE

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BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4006
Device Problems Sparking (2595); Patient Device Interaction Problem (4001)
Patient Problem Burn(s) (1757)
Event Date 11/15/2019
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 cartioverting a male patient (age unknown), they observed a spark and then heard an arc from the electrode pads. After removing the electrode pads, burns were found on the patient. Patient sustained burn marks. The customer was unable to provide what degree burn the patient received.
 
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Brand NamePRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
Type of DeviceDEFIB/PACING 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 Key9469041
MDR Text Key170860422
Report Number1218058-2019-00170
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/10/2020
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number3219
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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