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

Model Number	8900-0218-40
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
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 during training by facility staff, the device failed to discharge.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The onestep pediatric pads were returned to zoll medical corporation for evaluation.A visual inspection determined the pads were assembled correctly; however, the back of the electrode pad had been separated in half and then reattached.The customer provided a video for review.The video shows that the customer was not following the ifu.The user pulled the pads out from the pad corner not from a red tab.The instructions for use for onestep pediatric cpr electrodes state: "grasp the back/sternum electrode from the bottom red tab and peel from the plastic liner." the pads were scrapped and the customer was sent a replacement set of pads.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP PEDIATRIC
• Common Device Name: ELECTRODE PADS
• 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: 20684091
• Report Number: 1218058-2024-00103
• Device Sequence Number: 12893927
• Product Code: LDD
• UDI-Device Identifier: 00847946016234
• UDI-Public: (01)00847946016234(17)241105(10)4522
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 11/05/2024
• Device Model Number: 8900-0218-40
• Device Lot Number: 4522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• 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