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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 False Reading From Device Non-Compliance (1228); Communication or Transmission Problem (2896); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
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 during functional testing, the associated device recognized the attached adult electrodes as pediatric electrodes. Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation evaluated the electrodes and the reported malfunction was not replicated or confirmed. Testing of the electrodes with test device's did not duplicate the malfunction. Replacement electrodes were sent to the customer. No trend is associated with reports of this type.
 
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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 Key5960682
MDR Text Key55425250
Report Number1218058-2016-00129
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 09/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/03/2018
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number2316A
Other Device ID Number00847946016272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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