MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number D320

Device Problem High impedance (1291)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Rv lead has high impedance.Connection check is recommended (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISITION CORP
• MDR Report Key: 17523473
• MDR Text Key: 321446805
• Report Number: MW5130421
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: D320
• Patient Sequence Number: 1