MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE, 12CASE; ELECTRODES, DEFIBRILLATOR

Model Number	8900-2105-01
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 device would not convert the patient's heart rhythm.The clinicians obtained another device and were able to convert the patient to a normal sinus rhythm.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1218058-2021-00099 for a similar report from the same customer.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads and the customer's report was not replicated or confirmed.The electrode pads were put through extensive testing including continuity testing without duplicating the report.The pads were tested and found to deliver energy within specification and were found to pass all continuity testing.With no device or clinical logs for review, we are unable to confirm the customer's complaint.It is noteworthy to mention an inability to convert is not an indication of a device malfunction and can occur from various outside factors, including but not limited to, patient preparation, electrode placement, energy selection, or patient physiology/condition.No trend is associated with reports of this type.

• Brand Name: PRO-PADZ RADIOLUCENT LIQUID GEL ELECTRODE, 12CASE
• Common Device Name: ELECTRODES, DEFIBRILLATOR
• 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: 12206786
• Report Number: 1218058-2021-00100
• Device Sequence Number: 4376797
• Product Code: MKJ
• UDI-Device Identifier: 10847946016408
• UDI-Public: 10847946016408
• 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): 07/08/2021

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: 11/05/2021
• Device Model Number: 8900-2105-01
• Device Catalogue Number: 8900-2105-01
• Device Lot Number: 4520A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• 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: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 128 KG