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

Model Number 8900-000219-01

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event 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.

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)
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12436237
• MDR Text Key: 270300459
• Report Number: 1218058-2021-00116
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO