MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES CURAPLEX MULTI-FUNCTION DEFIBRILLATION ELECTRODE; DEFIBRILLATOR PAD

Model Number	16381
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Superficial (First Degree) Burn (2685)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation in ongoing because it is pending the analysis of the returned samples.Report to be updated once this is completed.
Event or Problem Description
On (b)(6) 2021 customer boundtree/ curaplex emailed nissha customer service the following report of complaint event: (b)(6) co was working a cardiac arrest a couple of days ago and when they pressed the "shock" button on the defibrillator, sparks and arcing shot out from the pads and apparently also burned the patient.As per the chief of the fire department, the sequence he described was as follows: male patient presented in cardiac arrest.Defib pads applied.First shock delivered in pt house was successful.Moved pt to ambulance.Shocked again for second time [ and this is the shock that produced the sparks.However, the defibrillation was successful and they achieved rosc.Delivered pt alive to hospital, however he later died (not due to the pads).The chief was asked if the pads could have been dislodged and adhesion compromised during the move from the house to the ambulance and although the chief of ems was not present, he stated that the paramedics on scene assured him that the pads were placed correctly.The patient did receive burns/injury from event, but died of other causes.
Event or Problem Description
On (b)(6) 2021 customer boundtree/ curaplex emailed (b)(6) customer service the following report of complaint event: robertson co was working a cardiac arrest a couple of days ago and when they pressed the "shock" button on the defibrillator, sparks and arcing shot out from the pads and apparently also burned the patient.As per the chief of the fire department, the sequence he described was as follows: male patient presented in cardiac arrest defib pads applied.First shock delivered in pt house was successful.Moved pt to ambulance shocked again for second time[ and this is the shock that produced the sparks.However, the defibrillation was successful and they achieved rosc.Delivered pt alive to hospital, however he later died (not due to the pads).The chief was asked if the pads could have been dislodged and adhesion compromised during the move from the house to the ambulance and although the chief of ems was not present, he stated that the paramedics on scene assured him that the pads were placed correctly.The patient did receive burns/injury from event, but died of other causes.

• Brand Name: CURAPLEX MULTI-FUNCTION DEFIBRILLATION ELECTRODE
• Common Device Name: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• MDR Report Key: 11904431
• Report Number: 1317188-2021-07233
• Device Sequence Number: 3856566
• Product Code: MLN
• UDI-Device Identifier: 00815277023894
• UDI-Public: (01)00815277023894(10)Y111220-04(17)231112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K080421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: 16381
• Device Lot Number: Y111220-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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