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U.S. Department of Health and Human Services

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

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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA, SINGLE Back to Search Results
Model Number 8900-0225-01
Device Problems Arcing of Electrodes (2289); Sparking (2595); Patient Device Interaction Problem (4001)
Patient Problem Burn(s) (1757)
Event Date 08/31/2020
Event Type  Injury  
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 cardiovert a patient (age & gender unknown), sparks and smoke were seen coming from the attached electrode pads. After removing the electrode pads, burns were found on the patient's skin. Complainant indicated that the patient subsequently sustained a burn. The severity of the burns sustained was not available. Please reference medwatch report number 1218058-2020-00087 for a similar report from the same customer.
 
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Brand NameELECTRODES, ONESTEP CPR AA, SINGLE
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 Key10819616
MDR Text Key215614569
Report Number1218058-2020-00089
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number8900-0225-01
Device Catalogue Number8900-0225-01
Device Lot Number2320C
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 Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/10/2020 Patient Sequence Number: 1
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