ULTRASOUND-GE 400 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-19 for ULTRASOUND-GE 400 * manufactured by General Electric Medical Systems.

Event Text Entries

[160012] The rptr recently became aware of a software error while utilizing the device. The rptr states that the device analyzes (via ultrasound) various "sizes" of a fetus, and creates ratios based on this data. The rptr states that certain ratios are only of value during certain states of the gestational period. He states that even though a ratio may not be applicable during a certain gestational period, the device will generate a ratio, and display this value as "abnormal". The rptr feels that this is problematic for two reasons: if an md is not thoroughly reading the results, they may incorrectly inform a pt that she has an "abnormal" pregnancy; and if a dr is used to ignoring the "abnormal" readings, they may, in fact, overlook a true abnormal result. The rptr states that a competitor's software generates "na" for values that would be incorrectly represented by the ratio. He feels that this software should be designed in the same manner. The rptr contacted the mfr regarding this event, and he was told that 50 md's were asked if this would be a problem, and they stated that "it was ok". The rptr does not believe that this info is correct/adequate. To the rptr's knowledge, no pt injury has been sustained as a result of this error.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016765
• MDR Report Key: 232494
• Date Received: 1999-07-19
• Date of Report: 1999-07-19
• Date Added to Maude: 1999-07-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRASOUND-GE 400
• Generic Name: ULTRASOUND
• Product Code: LXE
• Date Received: 1999-07-19
• Model Number: GE 400
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 225375
• Manufacturer: GENERAL ELECTRIC MEDICAL SYSTEMS
• Manufacturer Address: 3000 N. GRANDVIEW BLVD WAUKESHA WI 53186 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-07-19