MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, STAT PADZ

Model Number	8900-4003
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2017
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 & gender unknown), when removing the electrode pads from the packaging the gel adhered to the plastic packaging.Complainant indicated that the clinician obtained another set of electrode pads 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 electrode pads were returned to zoll medical corporation; the gel was observed to be attached to the styrene.Visual inspection showed the front/apex pad was inside the package and folded onto itself with the conductive gel rolled into a ball on the front/apex pad conductive plate.Our investigation was inconclusive on how this may have occurred.Evaluation of the retains did not reveal any irregularities that would have contributed to the reported event.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, STAT PADZ
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7191185
• Report Number: 1218058-2018-00004
• Device Sequence Number: 141194
• Product Code: MKJ
• UDI-Device Identifier: 10847946016453
• UDI-Public: 10847946016453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/26/2017

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: 11/12/2019
• Device Model Number: 8900-4003
• Device Catalogue Number: 8900-4003
• Device Lot Number: 4617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1