MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT*PADZ II ADULT MULTI-FUNCTION ELECTRODES (1 PA; DEFIB/PACING ELECTRODES

Model Number	8900-0801-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during functional testing, the associated defifbrillator displayed a "plug in cable" message when these electrode pads were attached.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer's report was duplicated and attributed to the returned stat-padz ii electrodes.The stat-padz ii electrodes were scrapped and a set of replacement electrode pads were sent to the customer.Analysis of reports of this type has not identified an increase in trend.

• Common Device Name: DEFIB/PACING ELECTRODES
• 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: 16516220
• Report Number: 1218058-2023-00048
• Device Sequence Number: 11424299
• Product Code: MKJ
• UDI-Device Identifier: 00847946016326
• UDI-Public: 00847946016326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/16/2023

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: 10/22/2024
• Device Model Number: 8900-0801-01
• Device Catalogue Number: 8900-0801-01
• Device Lot Number: 4322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2022
• 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