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

Model Number	8900-2106-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while cardioverting a patient (age & gender unknown), sparking was seen coming from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1218058-2019-00167 for a similar report from the same customer.
Additional Manufacturer Narrative
Zoll medical corporation received two sets of radiolucent electrodes for evaluation.Our evaluation of the electrodes did reveal energy concentration spots on both of the electrode pads.Additionally, a heavy presence of hair, skin debris and skin residue were evident.Without the device return and review of the log (not available), it is not known if, at the time of the shock event, the device sensed a higher than normally expected impedance and thus delivered a proportional current.Due to the state of the pads with an excess of hair/skin/debris, the evidence of arcing on the electrodes, this claim is being attributed to poor coupling of the electrode pads to the patient's skin.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ LIQUID GEL RADIOLUCENT MFE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9444379
• Report Number: 1218058-2019-00166
• Device Sequence Number: 2026154
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/19/2019

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: 10/21/2020
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Device Lot Number: 4319A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1