MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT PADZ; ELECTRODE

Model Number	8900-0400
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Information (3190)
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 obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another set of 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
This report was inadvertently submitted as a duplicate.The reported event was originally reported under medwatch 1220908-2020-00688.Evaluation results were: the device was returned to zoll medical canada and the customer's report was observed during review of the device activity logs.However, the device was put through extensive testing including full functionality testing, stress testing and ecg signal testing without duplicating a malfunction to the device.Visual inspection of the electrode pads returned found that one of the high voltage wires appeared to be cut.It is not known if the damage occurred during use or after.Review of the logs does appear to show the device worked flawlessly upon replacement of the electrodes for the remainder of the case.No trend is associated with reports of this type.

• Brand Name: CPR STAT PADZ
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9866226
• Report Number: 1218058-2020-00022
• Device Sequence Number: 14172661
• Product Code: MKJ
• UDI-Device Identifier: 10847946016316
• UDI-Public: 10847946016316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 8900-0400
• Device Catalogue Number: 8900-0400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1