MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES CURAPLEX MULTIFUNCTION DEFIB PAD, PHILIPS, ADULT NISSHA VERMED; DEFIBRILLATOR PAD

Model Number	16250
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that end user ems stated that while attempting to use 16250 curaplex multifunction defib pad, philips, adult nissha vermed - 6600204h, lot y120720-01, that the "pad will connect, but device will tell them that the pad is not connected".There was no patient injury or death involved with the event.The end user says the product is available for return and evelaution, but as of 6/24/2021, it has not been received.The customer reported they used with philips aed.No adapter.

• Brand Name: CURAPLEX MULTIFUNCTION DEFIB PAD, PHILIPS, ADULT NISSHA VERMED
• Common Device Name: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• MDR Report Key: 12063180
• Report Number: 1317188-2021-07344
• Device Sequence Number: 14408073
• Product Code: MLN
• UDI-Device Identifier: 00815277023832
• UDI-Public: (01)00815277023832(10)Y120720-01(17)231220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 12/07/2023
• Device Model Number: 16250
• Device Catalogue Number: 6600204H
• Device Lot Number: Y120720-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/24/2021
• 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