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

Model Number	8900-000219-01
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
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 pediatric patient (gender unknown), the electrode pads were unable to be removed from the packaging.The electrodes subsequently ripped causing unnecessary delay in patient care while the clinician applied ecg leads to continue cardiac monitoring of the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrodes and the reported malfunction was observed.Visual inspection of the electrodes found the electrodes adhered to the non-coated side of the styrene liner.There is definitive evidence based on the self test wire assembly suggesting the electrodes were originally adhered to the coated side of the liner for easy removal.It was determined that the electrodes were removed from the liner then reapplied back onto the noncoated side likely during the event.No trend is associated with reports of this type.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7382478
• Report Number: 1218058-2018-00020
• Device Sequence Number: 16175050
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: 08/19/2019
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 3417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1