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

Model Number	8900-0221-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
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 electrode pads were unable to attach to the patient's skin.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The onestep pads were returned to the zoll pawtucket for evaluation.The pads were received unsealed within the pouch attached to two separate styrene covers, with the back electrode placed on the incorrect side of the styrene.The styrene that is attached to the front electrode is cut in a shape that does not align with the back electrode's styrene.The back pad could not be removed from the styrene, however the gel appeared to be rolled into a ball on top of the tin.Given the conditions the pads were returned in, it cannot be determined how the gel had rolled.The onestep pads were scrapped after testing and appeared to pass all peformance criteria.The customer was sent replacement pads.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP
• 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: 19375488
• Report Number: 1218058-2024-00052
• Device Sequence Number: 7466353
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: (01)00847946016241(17)251203(10)4923
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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 Expiration Date: 12/03/2025
• Device Model Number: 8900-0221-01
• Device Catalogue Number: 8900-0221-01
• Device Lot Number: 4923
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown