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)
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 treat a (b)(6) female patient, after a 24 hour placement of the electrode pads on the patient, upon removal of the pads, burns were found on the patient.Complainant did not indicate if additional treatment for the burns sustained were required.Please reference medwatch report 1220908-2019-00027 and 1220908-2019-00028 for similar events reported from the same customer.
Additional Manufacturer Narrative
After reviewing details from the customer during an onsite visit and photographs of the areas of concern on the patient, zoll believes that the patient's skin irritations reported were more likely to be a skin burn after 24 hours of pad placement on the patient.The location of burns indicated poor pad placement (burns located in or around the patient's armpits).No defibrillations or pacing were performed on this patient.The instructions for use provides diagrams and specific instructions on good placement and warns against placing pads of folds of skin.Electrode labeling also provides instruction for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur.The electrode pads were not available for evaluation.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: 8497402
• Report Number: 1218058-2019-00029
• Device Sequence Number: 1062241
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 8900-4004
• Device Catalogue Number: 8900-4004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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: 60 YR