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

Model Number	16384
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted retrospectively as a result of an fda inspection in february of 2021.Corrective actions related to that inspection included a re-review of all complaints reported in the past 3 years.
Event or Problem Description
There was no death or serious injury reported as a result of event.A malfunction was reported, although unconfirmed through investigation.As per the end user, " the pacer pads failed to work.Pacer pads were placed upon the patient initially.The standard limb leads had to be put on immediately following the pacer pads in order to show a rhythm.The monitor showed nothing with just the pacer pads." the user reported that the pads were "plugged in" and then the pacer cord attached to the monitor was disconnected and then reconnected, and then the monitor was turned off and then back on.The user stated when they replaced the pads they worked and this confirmed to them that is was an issue with the pads and not the monitor.The end user confirmed that while trouble shooting, the monitor leads were placed onto the patient to confirm the rhythm to prevent interruption of patient care.

• Brand Name: CURAPLEX MULTI FUNCTION DEBIBRILLATION ELECTRODE
• Common Device Name: DEFIBRILLATOR PADS
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• MDR Report Key: 11641805
• Report Number: 1317188-2021-05888
• Device Sequence Number: 17120920
• Product Code: MKJ
• UDI-Device Identifier: 00815277023931
• UDI-Public: (01)00815277023931(10)Y110218-03(17)211102
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2021
• Device Model Number: 16384
• Device Lot Number: Y110218-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• 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