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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. GE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. GE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number PATIENT DATA MODULE
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 02/28/2023
Event Type  malfunction  
Event Description
Nurse attempted to take a blood pressure of a patient and was unable to.Also replaced the cuff and the tubing with the same result so the module was taken out of service and returned to the manufacture for a warranty repair.Manufacturer response for monitor, physiological, patient (with arrhythmia detection or alarms), ge (per site reporter).They replaced the main board and calibrated.
 
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Brand Name
GE
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 w tower ave
milwaukee WI 53223
MDR Report Key16589859
MDR Text Key311750654
Report Number16589859
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00840682104784
UDI-Public(01)00840682104784
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/13/2023
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 Operator Health Professional
Device Model NumberPATIENT DATA MODULE
Device Catalogue Number2016793-103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2023
Device Age10 MO
Event Location Hospital
Date Report to Manufacturer03/22/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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