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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC 5500 HD ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC 5500 HD
Device Problems Keyboard/Keypad (475); Cover (772); Crack (1135); No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2018
Event Type  Malfunction  
Event Description

Failure of part number 2031810-002 fru universal writer (lower case of the unit). This failure has lead to other damage including the unit will power on but the display is blank, the bottom case where the unit attaches to the trolley is cracked, the cover of the key board is cracked.

 
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Brand NameMAC 5500 HD
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 w tower ave
milwaukee WI 53223
MDR Report Key8008708
MDR Text Key125129680
Report Number8008708
Device Sequence Number1
Product Code DPS
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 10/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMAC 5500 HD
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2018
Device Age8 mo
Event Location Hospital
Date Report TO Manufacturer10/26/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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