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

Model Number CARESCAPE CICV1

Device Problems No Display/Image (1183); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

Failure of patient monitoring system in the emergency department.Staff in the emergency department unable to see patient vs on main monitor.Could view them in the individual patient rooms.Monitors routed to icu patient monitoring status staffed 24/7 by a monitor tech.Tech came out and determined this was a hard drive failure.A new hard drive was ordered and replaced.Patient central station is now functioning.

• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS; 465 pan american dr ste 11; el paso TX 79907
• MDR Report Key: 15410412
• MDR Text Key: 299783989
• Report Number: 15410412
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022,01/26/2021

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
• Device Model Number: CARESCAPE CICV1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1