MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS US, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE

Model Number ACUSON X300 PE

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problem No Information (3190)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted when the investigation has been completed.

Event Description

Upon receipt of this complaint, the inquiries to the patient outcome were requested.The response indicates the patient was unaware of their pregnancy and therefore fetal health and age were unknown at the time of the patient's visit.The lapse of 10 minutes in ultrasound imaging resulted in the delay of information regarding fetal blood flow.It is unknown how the doppler information would have been used to change his clinical management in light of the abnormal ctg (cardiotocography (ctg) is a technical means of recording the fetal heartbeat and the uterine contractions during pregnancy.It is a screening method used in pregnancy to identify fetuses at risk of developing hypoxia) test results that ere available at the time.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS US, INC.; mountain view CA 94043
• Manufacturer Contact: karen smith ; 685 east middlefield road; mountain view, CA 94043
• MDR Report Key: 5581994
• MDR Text Key: 42870859
• Report Number: 3009498591-2016-00036
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 072676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: ACUSON X300 PE
• Device Catalogue Number: 10566144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability