MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ HVP MULTI FUNCTION ELECTRODES; DEFIB/PACING ELECTRODE

Model Number	8900-4004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/31/2020
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 attempting to pace a (b)(6) male patient, for about 12 hours, after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently sustained a burn.
Additional Manufacturer Narrative
The electrodes were not received at zoll medical corporation.Instead, photos of the patient's burn and electrode pads used were provided.The patient suffered a small burn that measures about 1.5 centimeters.The photo of the electrode pads used show the area of the burn marked by a black smear and blood stain located on the rim of the conductive plate.The conductive gel also appears to be torn and folded over at the location of the burn.However, it cannot be firmly established if this occurred before or after the pad was removed from the patient.It is concluded that the electrode pads were used incorrectly.It is important to note that the instruction for use states "maximum pacing settings are 75ma/150ppm.Electrodes should be replaced after 24 hours, or 8 hours of pacing." during this event, the patient was paced for 12 hours with no evaluation of the patient's skin or change of electrodes.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: STAT PADZ HVP MULTI FUNCTION ELECTRODES
• Common Device Name: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10600659
• Report Number: 1218058-2020-00075
• Device Sequence Number: 2901122
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Expiration Date: 12/28/2020
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Device Lot Number: 5218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: 69 YR