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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL INFORMATION TECHNOLOGIES INC MAC 5500 EKG HD ELECTROCARDIOGRAPH

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GE MEDICAL INFORMATION TECHNOLOGIES INC MAC 5500 EKG HD ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC 5500
Device Problem Electromagnetic Interference (1194)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2016
Event Type  Malfunction  
Event Description

Staff note issues in obtaining clear ekgs. First one of the day is fine then the rest of the day they get worse. We replaced the older machine with a brand new and we are still having issues. It appears to be related to electrical interference.

 
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Brand NameMAC 5500 EKG HD
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL INFORMATION TECHNOLOGIES INC
8200 w tower ave
milwaukee WI 53222
MDR Report Key5768592
MDR Text Key48720973
Report Number5768592
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2016
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMAC 5500
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2016
Device Age1 dy
Event Location No Information
Date Report TO Manufacturer07/01/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/05/2016 Patient Sequence Number: 1
Treatment
NO
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