• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC MAC 5500 HD ELECTROCARDIOGRAPH Back to Search Results
Model Number 5500 HD
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2018
Event Type  Malfunction  
Event Description

Patient seen in emergency room with complaints of shortness of breath, diaphoresis, chest pain, and headache. The nurse was attempting to get an ecg, but the mac 5500 hd gave an error message "limb lead disconnected". The nurse replaced the leads and attempted to get an ecg again, but the mac 5500 hd kept giving the same error message. The mac 5500 hd was replaced with another system, and the nurse was able to get an ecg. No untoward patient effects.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAC 5500 HD
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 innovation drive
wauwatosa WI 53226
MDR Report Key7796619
MDR Text Key117572530
Report Number7796619
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 RISK MANAGER
Type of Report Initial
Report Date 07/23/2018,07/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5500 HD
Device Catalogue Number018344
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2018
Event Location Hospital
Date Report TO Manufacturer08/20/2018
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

-
-