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

Model Number	16384
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted retrospectively as a result of an fda inspection in february 2021.As a corrective action to that inspection a re-review of complaints was performed for reportability criteria.
Event or Problem Description
An end user ( ems) reported that a patient presented already in cardiac arrest."curaplex pads were placed on patient, shock delivered and monitor confirmed but the ecg confirmed it didn't deliver the shock." the ems removed the pads, placed physio control pads ( different product) and shock delivered per monitor and confirmed with ecg.Although second shock was able to be delivered, the patient did not survive the event.Originally the end user was going to return the product for evaluation and further investigation, but then confirmed they were no longer available.Follow up information from the user found that the user was trained on how to use the product, the pads were used with a physio control lifepak 15 unit, the pads was being used during an emergency cardiac arrest on a female patient, with energy setting of 200j.The end user stated, no shock was delivered but there was an ecg signal present.Per the user there was no audible alarm from the unti and the device was discarded at the hospital.

• Brand Name: CURAPLEX MULTI FUNCTION ELECTRODE
• Common Device Name: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL; 400 exchange street; buffalo NY 14204
• MDR Report Key: 11641817
• Report Number: 1317188-2021-07046
• Device Sequence Number: 3909594
• Product Code: MLN
• UDI-Device Identifier: 00815277023931
• UDI-Public: (01)00815277023931(10)Y031920-10(17)230319
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: 16384
• Device Lot Number: Y031920-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 04/09/2021
• 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: Death