MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE

Model Number	8900-000219-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while pacing a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that patient sustained burns to the skin.Information on the severity/degree of the burns was not available.
Event or Problem Description
Complainant alleged that while pacing a 2 year old male patient, after removing the electrodes pads, burns were found on the patient's skin.Complainant indicated that patient sustained burns to the skin.Information of the severity/degree of the burns was not available.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: zoll medical corporation received a pair of electrode pads.However, the electrodes appeared to be in a compromised condition.The electrodes were adhered together and unfortunately, were damaged upon an attempt to separate them for testing.A visual inspection of the electrodes did find evidence that they were used for therapy.Debris was observed on the top corner of the apex pad.The gel on the sternum pad was missing and the conductive plates had some discoloration.Due to the condition of the pads received, it was unsafe to perform any electrical testing.Information from the customer's report that a 2 year old male patient was paced using a setting of 90ma with a rate of 140ppm for 6 to 7 hours is an indication that the device was used incorrectly.Our instruction for use clearly states that the maximum pacing settings are 75ma at 150ppm.The electrode should be replaced after 24 hours or 1 hour of pacing.In this customer's report, the patient was paced for over 6 hours with no evaluation of the patient's skin or change of electrode pads as instructed.Burns of the skin are not unexpected when pacing during extended periods.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10369658
• Report Number: 1218058-2020-00059
• Device Sequence Number: 19047567
• Product Code: MKJ
• UDI-Device Identifier: 10847946016354
• UDI-Public: 10847946016354
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Other
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 YR
• Patient Weight: 13