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

MAUDE Adverse Event Report: NEXTGEN EMR - MEDICAL DEVICE NONE

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

NEXTGEN EMR - MEDICAL DEVICE NONE Back to Search Results
Event Date 06/01/2008
Event Type  Malfunction  
Event Description

My physician's office began using nextgen emr. The nurse entered in my son's info and then his heart rate. The software flagged his heart rate -almost as a vital sign monitoring function- as abnormal and told the nurse to take action. However, my son's heart rate was normal for an 8 mo infant at 120 beats/min. The software seems to not be properly validated as it misguided the nurse on treatment of an infant. Luckily, the nurse knew better and knew that my infant son's heart rate was normal. I am concerned that this malfunction and others that may exist could prompt incorrect treatments/actions by a nurse or physician if they were to recur, especially if under a stressed environment. Diagnosis: electronic pt record mgmt sys.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXTGEN EMR - MEDICAL DEVICE
Type of DeviceNONE
Device Event Key1025280
MDR Report Key1055515
Event Key1013646
Report NumberMW5007119
Device Sequence Number1
Product CodeHGM
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 06/02/2008 Patient Sequence Number: 1
-
-