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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, SINGLE DEFIB/PACING ELECTRODE

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BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4006
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), a spark was emitted from the electrode pad. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
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Brand NamePRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE
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 Key13043026
MDR Text Key282714985
Report Number1218058-2021-00144
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 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number3221A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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