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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE MAC 5500 ELECTROCARDIOGRAPH

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GE HEALTHCARE MAC 5500 ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC 5500
Device Problem Incorrect Measurement (1383)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969)
Event Date 09/10/2016
Event Type  Malfunction  
Event Description

Patient arrived to er via ems with complaints of chest pain. Patient diagnosed with stemi and code was called. After code completed, it was discovered that the ekg machine was not properly timed and stamped the code call 3 minutes before it was actually performed.

 
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Brand NameMAC 5500
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE HEALTHCARE
9900 innovation dr.
rp2138
wauwatosa WI 53226
MDR Report Key6089535
MDR Text Key59512843
Report Number6089535
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 09/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMAC 5500
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2016
Event Location Hospital
Date Report TO Manufacturer09/29/2016
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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