MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)

Model Number	8900-000219-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 indicated that while anticipating the treatment of an already deceased (b)(6) old female patient, that a wire had become dislodged from the electrode pad.Complainant indicated that upon assessment of the patient, mottling and rigor mortis were apparent prior to use of the device.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads and the customer's report was not replicated or confirmed.The electrodse pads were received without its original packaging.The pads were adhered to each side of the styrene line (one pad on the coated side of the styrene liner and one pad on the non-coated side).Visual inspection found the cables that are connected from the defib connector to the pads are still firmly intact to the pads.The only disconnected wire observed was the self-test shorting wire which is designed to disengage from the pads when the package is opened.A retained sample testing was performed on lot 4419, however no indication of any failures were found during the retained sample evaluation.The electrode pads were put through extensive testing including stress testing with a test device by shocking into a simulator without issue.The electrode pads were scrapped and replacement electrode pads were sent to the customer.No trend is associated with reports of this type.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12436237
• Report Number: 1218058-2021-00116
• Device Sequence Number: 5360972
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 08/17/2021

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: 10/29/2021
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 4419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO