MAUDE Adverse Event Report: SIEMENS SOARIAN; EHR/MDDS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Myocardial Infarction (1969)

Event Date 08/04/2014

Event Type  Injury  

Event Description

The vital signs on this patient were electronically sent to the ehr.The heart rate at rest was between 100 and 120 bpm with end stage heart function and some type of respiratory symptoms.Associated with the rush to beat the 23 hour observation deadline, the patient was discharged from the hospital without consideration of the resting tachycardia, because the number was silent in the vital signs silo out of sight and out of mind.The patient went on to suffer a myocardial infarction, associated with the failure to manage the "silent" tachycardia.Just who receives and addresses the vital signs in electronic data systems? the device, at least, is defective for failing to warn with its decision support; and it has had a negative influence on workflow communication and data analysis.

• Brand Name: SOARIAN
• Type of Device: EHR/MDDS
• Manufacturer (Section D): SIEMENS; malvern PA 19355
• MDR Report Key: 4046855
• MDR Text Key: 15323247
• Report Number: MW5037935
• Device Sequence Number: 1
• Product Code: LNX
• 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: 08/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 78