MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, TRAINING ONESTEP A/A W/CABLE

Model Number 8900-0240-01

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during biomed testing, the technician received an unintended delivery of energy.Complainant did not indicate that there was any adverse effect to the technician due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation.The customer's report of the wire that is going into the connector broke and the trainer received a shock from the cable could not be confirmed.The training cable being used works as a pass through for live defibrillation into a patient simulator.The cable connects to a zoll defibrillator and has a split connection, where electrode pads are applied to a training mannequin and the live feed attaches to a patient simulator.No electrical current is conducted through the training electrode pads.The connection between the multifunction cable and the patient simulator is where the cable would have to fail in order for the user to receive a shock as stated.No trend is associated with reports of this type.

• Brand Name: ELECTRODES, TRAINING ONESTEP A/A W/CABLE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10516289
• MDR Text Key: 206381442
• Report Number: 1218058-2020-00069
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0240-01
• Device Catalogue Number: 8900-0240-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other