MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE; ELECTRODES

Model Number	8900-000219-01
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
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 product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a 2-month-old male patient, the electrode pads were damaged during the removal of packaging.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.It's noteworthy to mention; the instructions for use (ifu) for onestep pediatric cpr electrodes state: 'grasp the back/sternum electrode from the bottom red tab and peel from the plastic liner.'.

• Brand Name: ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE
• Common Device Name: ELECTRODES
• 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: 20085821
• Report Number: 1218058-2024-00082
• Device Sequence Number: 18095339
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: (01)00847946023348(17)251008(10)4123A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/08/2024

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: 10/08/2025
• Device Model Number: 8900-000219-01
• Device Lot Number: 4123A
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2023
• 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 Age: 2 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Race: White