MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE; RLRCTRODES

Model Number	8900-2105-01
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/22/2017
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 defibrillate a (b)(6) male patient, the electrode pads would not adhere to the patient's skin.Complainant indicated that the clinician obtained two more sets of electrode pads, same lot number 3617, with the same result as the first set.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Please reference medwatch reports 1218058-2017-00139, 1218058-2017-00141, and 1218058-2017-00142, for similar events reported from the same customer.
Additional Manufacturer Narrative
The electrode pads were returned to zoll medical corporation; the liquid gel from the center sponge was observed in several places on the adhesive foam.It was determined the liquid gel affected the adhesive properties of the foam, which inhibits patient/electrode adhesion.Evaluation of the retain electrodes did not reveal any irregularities that would have contributed to the reported event.It is noteworthy to mention the instructions for use warns "do not use if gel escaped from electrodes into packaging" and to "store flat".Analysis for reports of this type has not identified an increase in trend.Please reference medwatch reports 1218058-2017-00139, 1218058-2017-00141, and 1218058-2017-00142, for similar events reported from the same customer.

• Brand Name: PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE
• Common Device Name: RLRCTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7137462
• Report Number: 1218058-2017-00140
• Device Sequence Number: 1211249
• Product Code: MKJ
• UDI-Device Identifier: 10847946016408
• UDI-Public: 10847946016408
• 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): 12/04/2017

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: 09/03/2018
• Device Model Number: 8900-2105-01
• Device Catalogue Number: 8900-2105-01
• Device Lot Number: 3617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR