MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET; ELECTRODE

Model Number	8900-2106-01
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2022
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 attempting to defibrillate a (b)(6) male patient, the associated defibrillator failed to cardiovert the patient after three shocks with electrode pads at 200j.Complainant indicated that the clinician used an internal defibrillator.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1218058-2022-00023 for a similar report from the same customer.
Additional Manufacturer Narrative
The product used at the time of the report was not returned to zoll for evaluation.Instead, retain samples of pro padz electode lot 4821 were evaluated.The customer's report was not replicated or confirmed.The retained electrodes were put through extensive testing including electrical testing, lcr impedance testing, and continuity testing without duplicating the report.A visual inspection found the lot assembly built according to specification.Review of all records were performed and passed.Based on the evaluation of the retained samples it was concluded that the samples were assembled according to specification without duplicating the report.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 13895009
• Report Number: 1218058-2022-00024
• Device Sequence Number: 19909217
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 11/26/2022
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Device Lot Number: 4821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male