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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR
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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR Back to Search Results
Model Number 8900-0223-01
Medical Device Problem Code Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation for evaluation.The malfunction was attributed to an open wire (high voltage wire) within the electrodes.The electrodes were scrapped.The customer received a replacement set of electrodes to resolve the malfunction.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated device displayed a "poor pad contact" message with these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
ELECTRODES, ONESTEP CPR
Common Device Name
ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
MDR Report Key8705177
Report Number1218058-2019-00067
Device Sequence Number11231817
Product Code MKJ
UDI-Device Identifier00847946016265
UDI-Public00847946016265
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/26/2020
Device Model Number8900-0223-01
Device Catalogue Number8900-0223-01
Device Lot Number1918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2019
Initial Report FDA Received Date06/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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