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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK, INC. ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
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BIO-DETEK, INC. ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES Back to Search Results
Model Number 8900-0224-01
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Complainant alleged that during a routine shift check by a clinician, the electrodes caused the device to fail self test.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, SINGLE, R SERIES
Type of Device
ELECTRODE
Manufacturer (Section D)
BIO-DETEK, INC.
pawtucket RI
Manufacturer Contact
tina lombari
525 narragansett park dr.
pawtucket, RI 02861
4017291400
MDR Report Key4841809
MDR Text Key22154498
Report Number1218058-2015-00020
Device Sequence Number1
Product Code DRX
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 05/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2017
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number1315C
Other Device ID Number00847946016272
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/26/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2015
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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