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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA

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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA Back to Search Results
Model Number 9355-0961-01
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Death (1802); Laceration(s) (1946)
Event Date 03/21/2019
Event Type  Death  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while performing cpr on a (b)(6) female patient, the patient received lacerations from the cpr puck. Complainant indicated that new pads were applied and chest compressions were maintained. However, cpr was unsuccessful and the patient expired.
 
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Brand NameELECTRODES, ONESTEP CPR AA
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 Key8488244
MDR Text Key141083593
Report Number1218058-2019-00035
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number9355-0961-01
Device Catalogue Number9355-0961-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/05/2019 Patient Sequence Number: 1
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