MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ BISPHASIC MFE; ELECTRODE

Model Number	8900-2302-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Information (3190)
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 patient (age & gender unknown), the electrodes would not adhere to the patient's skin.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrode pads were not returned to zoll medical corporation for evaluation.No data file was available for review.A retain sample testing was performed on the same lot number 1419a, with no discrepancies found.Device history records were reviewed and this report was the first of it's nature.Without the electrode pads or the data files for review, we were unable to confirm the customer's report.

• Brand Name: PRO PADZ BISPHASIC MFE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8895028
• Report Number: 1218058-2019-00111
• Device Sequence Number: 289691
• Product Code: MKJ
• UDI-Device Identifier: 00847946016418
• UDI-Public: 00847946016418
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K895032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 12/31/2019
• Device Model Number: 8900-2302-01
• Device Catalogue Number: 8900-2302-01
• Device Lot Number: 1419A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1