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

Model Number 8900-0225-01

Device Problem Device Operational Issue (2914)

Patient Problem Burn(s) (1757)

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 after removing these defibrillation electrode pads from a patient (age & gender unknown), two small burn like injuries were found on the patient.

Manufacturer Narrative

The onestep cpr electrodes were returned for evaluation.The electrodes were visually evaluated and evidence of burns were found.A retained sample investigation was also conducted.The retained sample investigation resulted in no faults found and concluded that the retained electrodes were assembled according to specification.The associated defibrillator's involved passed testing and were recertified.Review of the device activity logs showed that the patient had been paced with these pads for 3 hours and 57 minutes and showed that the device was attached to the patient for 7 hours and 45 minutes.The onestep cpr electrodes instructions for use states "transcutaneous pacing longer than 30 minutes may cause burns to the skin.Periodically check the electrode site to ensure that the electrode is well adhered to the skin.Press over the entire surface of the electrode to ensure adhesion" and "for pacing times in excess of 2 hours, zoll recommends pro-padz with liquid gel".This report has been attributed to user error for pacing the patient over the recommended timeframes identified in the ifu.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR AA
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 7652684
• MDR Text Key: 112835792
• Report Number: 1218058-2018-00055
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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
• Device Operator: Other
• Device Model Number: 8900-0225-01
• Device Catalogue Number: 8900-0225-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1