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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE, 12CASE
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BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE, 12CASE Back to Search Results
Model Number 8900-2105-01
Medical Device Problem Code Smoking (1585)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/01/2020
Type of Reportable Event Malfunction
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 defibrillate a patient (age & gender unknown), flame was seen coming from the electrode pad.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
 
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Brand Name
PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE, 12CASE
Common Device Name
ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
MDR Report Key11185395
Report Number1218058-2021-00002
Device Sequence Number14181596
Product Code MKJ
UDI-Device Identifier10847946016408
UDI-Public10847946016408
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number8900-2105-01
Device Catalogue Number8900-2105-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/28/2020
Supplement Date Received by Manufacturer12/28/2020
Initial Report FDA Received Date01/18/2021
Supplement Report FDA Received Date02/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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