MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	V100
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with sustained ventricular tachycardia (vtach) to 160s for approximately 2 minutes.Ge telemetry reading medium level yellow alarm and reading rhythm at tachy.Registered nurse was at bedside providing patient care.Rapid response called when vtach event began.

• Brand Name: CARESCAPE
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 19497574
• Report Number: 19497574
• Device Sequence Number: 12755550
• Product Code: MHX
• UDI-Device Identifier: 00840682103091
• UDI-Public: (01)00840682103091
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/26/2024
• Report Date (Section F): 02/26/2024

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 Model Number: V100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 02/26/2024