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U.S. Department of Health and Human Services

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

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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE Back to Search Results
Model Number 8900-0224-01
Device Problem Human-Device Interface Problem (2949)
Patient Problem Laceration(s) (1946)
Event Type  Injury  
Manufacturer Narrative
The actual electrodes were not returned to zoll medical corporation for evaluation. A lot number was not provided, therefore review of a retained sample could not be performed. The customer's report could not be confirmed using the pictures provided by the customer. This claim will be closed as no sample returned. Analysis of reports of this type has not identified an increase in trend.
 
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 using electrode pads during a patient code, the electrodes were placed onto the patient, and the clinician chose to lift the electrode and re-adhere. When peeling the electrode from the patient, some of the gel came off the electrode and remained on the patient. When the electrode was re-applied and cpr was performed, the portion of the electrode that was missing the gel had folded over. The electrode had become loose and cut into the patients chest. Complainant indicated that the electrodes were not retained and the lot number is unknown. Complainant indicated that the patient required stitches subsequent to the event.
 
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Brand NameELECTRODES, ONESTEP COMPLETE
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 Key6424130
MDR Text Key113788527
Report Number1218058-2017-00035
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/22/2017 Patient Sequence Number: 1
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