MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE

Model Number	8900-000219-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/25/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (b)(6) year old female patient in severe bradycardia transitioned to pea, the associated device displayed a ?check pads? message using these electrode pads.Complainant indicated that the clinician performed cpr to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The electrodes were not returned to zoll medical corporation for evaluation.No clinical data or device activity logs from the event were provided for review.Information obtained from the customer during our investigation indicated that the patient was diaphoretic at the time of the event and a shock was not warranted for this patient.It is not known what type of patient prep was performed on the patient prior to attachment of the electrodes.The instructions for use for the electrodes indicate: "to ensure proper adherence, ensure skin is clean and dry.Remove any debris, ointments, etc with water (and mild soap if needed).Wipe off excess moisture/diaphoresis with dry cloth".Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8996541
• Report Number: 1218058-2019-00128
• Device Sequence Number: 3380321
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 4 YR