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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE
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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE Back to Search Results
Model Number 8900-0224-01
Device Problem Arcing of Electrodes (2289)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2016
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to cardiovert a patient (gender & age unknown) an arc was seen from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
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Brand Name
ELECTRODES, ONESTEP COMPLETE
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 Key5943240
MDR Text Key54838369
Report Number1218058-2016-00128
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 Other
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/27/2018
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number1816
Other Device ID Number00847946016272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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