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

Model Number	8900-2303-01
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/16/2018
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 displayed a "check pads" message using these electrode pads.Complainant indicated that the clinician obtained several sets of electrode pads (one same lot 1518 and one different lot 1218 - manufacture date of 3/19/2018 expiration date of 12/19/2019) to continue treating the patient and the "check pads" message appeared.The complainant indicated that this caused a delay in the treatment of 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 electrodes were not returned for evaluation.Instead, an un-opened set of electrode pads were returned.The reported problem could not be verified.The un-opened electrode pads returned passed visual inspection with no discrepancies noted.Two lots 1518 and 1218 were pulled for retained sample testing.None of the units resulted in a check pads message when subjected to simulated testing.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7574034
• Report Number: 1218058-2018-00045
• Device Sequence Number: 13511313
• Product Code: MKJ
• UDI-Device Identifier: 10847946016415
• UDI-Public: 10847946016415
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K895032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 01/07/2019
• Device Model Number: 8900-2303-01
• Device Catalogue Number: 8900230301
• Device Lot Number: 1518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1