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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 Problems Failure to Convert Rhythm (1540); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during a cardioversion on a patient (age & gender unknown), the device failed to cardiovert the patient's heart rhythm. During subsequent attempt to cardiovert the patient, an arc was heard 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 NameELECTRODES, ONESTEP COMPLETE
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 Key8949097
MDR Text Key156479787
Report Number1218058-2019-00119
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 08/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/03/2021
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number2319J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2019
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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