MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, MFE, PRO-PADZ, BIPHASIC; DEFIB/PACING ELECTRODE

Model Number	8900-2303-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), two sets of electrode pads needed to be replaced during chest compressions, causing unnecessary delays in delivering therapy.Complainant indicated that the clinician obtained a set of paddles to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
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 treat a patient (age & gender unknown), two sets of electrode pads needed to be replaced during chest compressions, causing unnecessary delays in delivering therapy.Complainant indicated that the clinician obtained a set of paddles to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The actual propadz electrodes from the event were not available for evaluation.Instead, electrodes from retained samples of the same lot number 4121c were investigated.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Review of the photo provided does show the gel not attached to the pad/conductive plate itself.However, this was after use on the patient.There is a significant amount of creasing visible along the conductive plate, which suggests that cpr was performed whilst pressing on the pads themselves.The product labeling specifically warns the users not to conduct chest compressions through the pads, as damage to the pads can occur.Without receipt of the pads or a log from the device utilized with the pads, a detailed investigation could not be conducted to determine the circumstances that led to the gel separation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, MFE, PRO-PADZ, BIPHASIC
• Common Device Name: DEFIB/PACING 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: 13525218
• Report Number: 1218058-2022-00006
• Device Sequence Number: 20182594
• Product Code: MKJ
• UDI-Device Identifier: 10847946016415
• UDI-Public: 10847946016415
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K895032
• 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): 01/24/2022

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: 07/08/2022
• Device Model Number: 8900-2303-01
• Device Catalogue Number: 8900230301
• Device Lot Number: 4121C
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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 Sex: Unknown