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

Model Number	8900-000219-01
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown) the electrodes could not be removed from the packaging.Complainant indicated that the clinician obtained another electrode to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation without the original outer packaging.The reported problem was observed during visual inspection.It was determined that the cause of the problem was due to both the front and back electrodes being stuck on the non-coated side of the styrene liner.It could not be determined if the electrodes were shipped in this condition by zoll, or were put in this condition by the operator.A retained sample investigation was performed for this lot number and the sample electrodes met specifications.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: 8557822
• Report Number: 1218058-2019-00037
• Device Sequence Number: 13951416
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/02/2020
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 1418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1