MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES CURAPLEX MULTIFUNTION DEFIBRILLATION ELECTRODE; DEFIBRILLATION PADS

Model Number	16384
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2020
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.A corrective action associated with that inspection included a re-review of all complaints and reportability criteria.
Event or Problem Description
On (b)(6) 2020, and end user reported that they were using the defib pads during a resuscitation attempt and the pads were" not reading / working on lp15." the connections were inspected, unplugged, and tried again with no reading.Another set of defib pads were used and could not get a reading for those.Very limited information was received from the customer and no samples were returned for investigation, although there were multiple attempts.A serious death or injury was not reported.

• Brand Name: CURAPLEX MULTIFUNTION DEFIBRILLATION ELECTRODE
• Common Device Name: DEFIBRILLATION PADS
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• MDR Report Key: 11641815
• Report Number: 1317188-2021-06684
• Device Sequence Number: 19810520
• Product Code: MLN
• UDI-Device Identifier: 00815277023931
• UDI-Public: (01)00815277023931(10)Y040820-10(17)230408
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Administrator/Supervisor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: 16384
• Device Lot Number: Y040820-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• 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