MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

Model Number	8900-0402
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
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 treat a patient (age & gender unknown), the associated device was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another set of defib pads 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 device was not returned to zoll medical corporation, but the clinical file was returned to conduct an investigation.Review of the provided clinical data file showed the device initially obtained an ecg signal via pads at 21:42:35 and indicated pads on.Cpr is being performed, and at 21:46:20, the signal is lost and pads off is displayed.The device then toggles between pads on and pads off for about eight minutes until there is a defib cable id change at 21:55:36.The pads off/pads on toggling indicate poor coupling between the pads and the patient, because if the poor coupling was between the unit and mfc or mfc to pads then defib cable id changes would have been registered in the log during that time.There is a pads on message and the defib is then able to charge and shock when the proper patient impedance criteria was met, which further supports that the poor coupling was between the pads and the patient.It's noteworthy to mention the x series operator's guide states: preparing the patient for electrode application: the proper application of electrodes is essential for high quality ecg monitoring.Good contact between the electrodes and skin minimizes motion artifact and signal interference.Before applying the electrodes, prepare the patient's skin, as necessary, shave or clip off excess hair at electrode site, clean oily skin with an alcohol pad, and rub site briskly to dry.Analysis of reports of this type has not identified an increase in trend.

• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 18816254
• Report Number: 1218058-2024-00016
• Device Sequence Number: 20928387
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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 Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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