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

Model Number	8900-0800-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to monitor a 50-60-year-old female patient, the electrodes would not adhere to the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d1 brand name updated, d4 catalog # removed, d4 primary udi # updated (this device has a udi; some information was not provided and is unknown; therefore, a complete udi cannot be provided).Evaluation results: zoll medical corporation evaluated the returned pads and retained samples from lot 3023b and the customer's report was not replicated or confirmed.The pads was put through extensive testing including peel testing and visual inspection without duplicating the report.A review of the device history record for lot 2023b showed the raw material passed initial evaluation at incoming inspection.After the evaluation, it was determined that the pads adhere as expected.The returned pads were scrapped after testing.No trend is associated with reports of this type.

• Brand Name: CPR-D PADZ
• 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: 18949295
• Report Number: 1218058-2024-00022
• Device Sequence Number: 12770080
• Product Code: MKJ
• UDI-Device Identifier: 00847946000189
• UDI-Public: 00847946000189
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K011541
• 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): 03/01/2024

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: 8900-0800-01
• Device Catalogue Number: 8900-0800-01
• Device Lot Number: 3023B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: Female