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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS CARESCAPE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
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GE MEDICAL SYSTEMS CARESCAPE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number ARK-2250L
Patient Problem Insufficient Information (4580)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
[redacted name] biomedical engineering was notified at around 17:30 on [redacted date] of a loss of patient telemetry waves for all patients on the v3 ge central station.This resulted in ¿no com¿ alarms for all patients and loss of all patient vitals¿ information.Initial troubleshooting involved a reboot of the ge central station locally on the unit, but this did not solve the issue.Clinical engineering was then contacted to further look into the v6 ge carescape telemetry server to identify any possible connectivity issues causing loss of patient waves.It was noted that within the local ¿webmin¿ screen of the server, a check of all telemetry towers on the network identified connectivity and other software related errors.Screenshots of the interface were taken for further documentation.The telemetry server was then reboot remotely and patient telemetry waves returned for the unit.In all, this resulted in about a 20min downtime of patient waves.
 
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Brand Name
CARESCAPE
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
GE MEDICAL SYSTEMS
3000 n. grandview blvd
waukesha WI 53188
MDR Report Key19142529
MDR Text Key340585359
Report Number19142529
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2024
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
Device Model NumberARK-2250L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2024
Device Age9 MO
Date Report to Manufacturer04/19/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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