MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE

Model Number 8900-0224-01

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Necrosis (1971)

Event Date 03/24/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) male patient, the electrodes would not adhere to the patient's skin during an attempt to defibrillate.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Manufacturer Narrative

The one step complete electrodes were returned to zoll medical corporation opened and appeared used.A visual inspection found the presence of pads creased, hair, skin, debris, and what appears to be a resemblance of dried blood.The evidence found on the pads can lead to poor coupling which can result in the pads not adhering to the patient.The returned pads passed ecg and shock testing without duplicating the report.Testing of the retained samples form lot 3920a passed adhesive testing.The electrodes were scrapped.To improve coupling/adhesion, the instructions for use states: "remove excess chest hair and ensure skin is clean and dry under electrode." analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11680449
• MDR Text Key: 245846991
• Report Number: 1218058-2021-00049
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/23/2022
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 3920A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR