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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK, INC. ELECTRODES, ONESTEP COMPLETE
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BIO-DETEK, INC. ELECTRODES, ONESTEP COMPLETE Back to Search Results
Model Number 8900-0224-01
Device Problem Arcing of Electrodes (2289)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Complainant alleged that while preparing a room for use, an arc was seen coming from the electrode pads after draping the pads over a stretcher.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
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Brand Name
ELECTRODES, ONESTEP COMPLETE
Type of Device
ELECTRODE
Manufacturer (Section D)
BIO-DETEK, INC.
pawtucket RI
Manufacturer Contact
tina loombari
525 narragansett park dr.
pawtucket, RI 02861
4017291400
MDR Report Key4683601
MDR Text Key16455384
Report Number1218058-2015-00001
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
Source Type Unknown
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/08/2016
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number0215
Other Device ID Number00847946016272
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/19/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2015
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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