MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR AA; ELECTRODE

Model Number	8900-0225-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), when applying these electrode pads to the patient, one of the pad's adhesive was stuck to the cover.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
Zoll australia's field development manager, went onsite and inspected a sample of eight electrodes from the same lot.No issues were identified during this evaluation, and photos and videos were taken to document the results.The team is in direct contact with the customer and is supporting them with training on proper electrode application through both video tutorials and printed instructions for use (ifus).Reviews of all records were performed and passed.Based on the evaluation of the retained samples, pre evaluation it was concluded that the samples were assembled according to specification without duplicating the report.A zoll representative communicated to the customer, if the red tab on the electrode pads is not used during removal from the packaging as illustrated on the pouch, it may result in damage to the electrode or difficulty removing the pads from the styrene linear.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP CPR AA
• 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: 22046405
• Report Number: 1218058-2025-00078
• Device Sequence Number: 9280167
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: (01)00847946016289(17)261126(10)4824A
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 8900-0225-01
• Device Lot Number: 4824A
• Was Device Available for Evaluation?: No
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• 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