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U.S. Department of Health and Human Services

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

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BIO-DETEK INCORPORATED ELECTRODES, PRO-PADZ ADULT RADIOLUCENT MULTIFUNCTI Back to Search Results
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.
 
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Brand NameELECTRODES, PRO-PADZ ADULT RADIOLUCENT MULTIFUNCTI
Type of DeviceELECTRODE
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 Key12434220
MDR Text Key270155069
Report Number1218058-2021-00117
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
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9600-0037
Device Catalogue Number9600-0037
Device Lot Number1521D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2021
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: 09/07/2021 Patient Sequence Number: 1
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