MAUDE Adverse Event Report: SIEMENS/CERNER ELECTRONIC MEDICAL RECORD EHR/MDDS

Device Problems Device Alarm System (1012); No Device Output (1435)

Patient Problem Loss of consciousness (2418)

Event Date 03/24/2016

Event Type  Injury  

Event Description

At our institution, no one sits in front of the ehr mdds terminal surveying the data of each patient as it gets deposited into the ehr mdds.Additionally, there is not any alarm or notification that new results arrived, nor is there a notice of any abnormal results.In this case, the serum sodium was dangerously elevated and was in the mdds, but because of the time of arrival and absence of notice, no one knew, resulting in further increase before intervention was ordered.The patient suffered altered level of consciousness and the hospitalization was prolonged.

• Brand Name: ELECTRONIC MEDICAL RECORD EHR/MDDS
• Type of Device: EHR/MDDS
• Manufacturer (Section D): SIEMENS/CERNER; kansas city MO 64117
• MDR Report Key: 5537447
• MDR Text Key: 41581356
• Report Number: MW5061344
• Device Sequence Number: 1
• Product Code: MWI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 72