MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

Model Number	8900-0800-01
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 product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), after removing the electrode pads, an abrasion was found on the patient's skin.Complainant indicated that the patient sustained burn marks.No information available to what degree the burns are.
Additional Manufacturer Narrative
This report was inadvertently submitted with the incorrect device and manufacturer information.Please reference medwatch number 1220908-2022-03880 with the correct device and manufacturer information.Evaluation results: the device was not returned to zoll medical corporation for evaluation.Instead, a photograph of the customer's report was provided.Review of the photograph did show the customer's report.However, it was determined this was an expected result given the patient preparation status.If the patient is not properly prepped there can be skin breakage during cpr as the hair is wrenched and pulled.A full dhr review for the part number and identified lots did not find any related complaints or discrepancies.The corpuls sensor has no therapy capabilities and the reddening observed cannot be from a burn from the delivery of electrical therapy.The corpuls sensor has undergone biocompatibility testing during it's design to ensure the materials being used were not likely to cause an adverse reaction.Furthermore, the benefit of providing high quality cpr when using the zoll cpr puck vastly outweighs the risk of receiving skin irritation during the cpr process.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR
• Common Device Name: 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: 14959729
• Report Number: 1218058-2022-00078
• Device Sequence Number: 5396497
• Product Code: MKJ
• UDI-Device Identifier: 00847946000189
• UDI-Public: 00847946000189
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• PMA/510(K) Number: K011541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 8900-0800-01
• Device Catalogue Number: 8900-0800-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown