MAUDE Adverse Event Report: NEXTGEN HEALTHCARE INFORMATION SYSTEM NEXTGEN FETAL AGE AND VITAL SIGN SYSTEM; NEXTGEN SYSTEM

Device Problems Defective Device (2588); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2013

Event Type  Injury  

Event Description

Re: defective medical product compromising pediatric patient care at (b)(6).Dear (b)(4), as a pediatrician, i feel the obligation to "suggest" to you that your company has sold a defective medical system to (b)(6).It compromises pediatric patient care.Nextgen lists gestational age (how long a baby was in his mother's belly) under vital signs (a list, how fast a heart beat is, how many times you breathe, how much blood pressure your heart generates and what temperature you have), which is a serious red flag, indicating that your programmer(s) were not familiar with medical terms, and that your nextcare system has not undergone quality control and safety evaluation before being used on pts.(b)(6) requires a full time employee to keep it "patched".It asks for a numbing number of irrelevant entries that are not ordered in any patient oriented way and hides the relevant positive and negative findings (when even there?) behind a multitude of confusing clicks, that the operator will become too tired to execute.This has now led to the absence of the standard medical documentation that was an integral part of the medical records at (b)(6) only months ago.Sooner or later, patients will be harmed by this defective emr system and liability questions be raised.Cc: (b)(6), fda's postmarket surveillance information and analysis branch.

• Brand Name: NEXTGEN FETAL AGE AND VITAL SIGN SYSTEM
• Type of Device: NEXTGEN SYSTEM
• Manufacturer (Section D): NEXTGEN HEALTHCARE INFORMATION SYSTEM
• MDR Report Key: 3695649
• MDR Text Key: 4294889
• Report Number: MW5035124
• Device Sequence Number: 1
• Product Code: HGM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention