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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 Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2016
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 while attempting to treat a (b)(6) male patient, the device inappropriately recognized these adult electrode pads as pediatric electrode pads. Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The event electrodes were returned for evaluation and the customer's report was not replicated or confirmed. A thorough evaluation of the electrodes was performed and no assembly or performance issues were found. Review of the device history log did not find evidence to support the customer's report. Based on the results, it was concluded there were no discrepancies with these electrodes. The customer received a replacement set of electrode pads. 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 Key6099140
MDR Text Key60295752
Report Number1218058-2016-00142
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 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/21/2018
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number2116A
Other Device ID Number00847946016272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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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