MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-09 for ULTRASOUND IMAGING SYSTEM 5200E * manufactured by Acoustic Imaging Technologies, Inc..
[21588468]
When using the "hadlock formula mode" during the 12 to 13 week period (1st trimester) to determine fetal calculations, the unit fails to calculate the average properly. Instead of appropriately averaging 13 weeks, the software causes an average of 14 weeks to be displayed thus giving the physician inaccurate data to diagnose the correct age of the fetus based on its size. The unit works fine in the "average mode. " software revisions 5. 51, 5. 53, 5. 6, and 5. 7 are affected and will miscalculate the fetus age when using the "hadlock formula mode. "rptr notified the mfr and its parent co and both said they are aware of the software problems. Rptr has determined that the software in fact is faulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001629 |
| MDR Report Key | 42103 |
| Date Received | 1996-10-09 |
| Date of Report | 1996-08-29 |
| Date Added to Maude | 1996-10-16 |
| 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 |
| Brand Name | ULTRASOUND IMAGING SYSTEM |
| Generic Name | DOPPLER ULTRASOUND FOR FETAL EVALUATION |
| Product Code | LXE |
| Date Received | 1996-10-09 |
| Model Number | 5200E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 43143 |
| Manufacturer | ACOUSTIC IMAGING TECHNOLOGIES, INC. |
| Manufacturer Address | 10027 51ST PHOENIX AZ 850445204 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-09 |