MAUDE Adverse Event Report: IVY BIOMEDICAL SYSTEMS, INC. MONITOR, CARDIAC (INCL. CARDIOTACHOMETER AND RATE ALARM)

Model Number MONITOR 3607-04-15 IVY CARDIAC TRIGGER

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device tracking (7) crf captures was damaged during technical testing.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER AND RATE ALARM)
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER AND RATE ALARM)
• Manufacturer (Section D): IVY BIOMEDICAL SYSTEMS, INC.
• MDR Report Key: 17537117
• MDR Text Key: 321520379
• Report Number: MW5143997
• Device Sequence Number: 1
• Product Code: DRT
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MONITOR 3607-04-15 IVY CARDIAC TRIGGER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1