MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for MERGE CADSTREAM 6.0.1.933 manufactured by Merge Healthcare.
[188863809]
The issue, incorrect patient orientation on all study images, was caused by incorrect data entry by a user at the mr scanner. This is not an issue or malfunction that was caused by the merge cadstream device. The cause of the incorrect orientation or laterality (left or right) is due to improper data entry by a technician at the scanner. No patient consequences, impact or harm was reported. No further action required. Merge cadstream is performing as designed.
Patient Sequence No: 1, Text Type: N, H10
[188863810]
Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies. Cadstream supports evaluation of dynamic mr data acquired during contrast administration. Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats). On (b)(6) 2020, merge technical support was contacted by a user at a facility for assistance with correcting a study scanned with incorrect patient laterality. The patient's laterality was entered at the scanner incorrectly. Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities. Study results have the potential to become part of the patient's permanent record and records have the potential to impact a patient's treatment, therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm. There is no indication that this issue as reported by the customer has resulted in any harm to a patient. Reference complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2020-00011 |
| MDR Report Key | 9879546 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2015-07-31 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BRIAN BELL |
| Manufacturer Street | 75 BINNEY ST |
| Manufacturer City | CAMBRIDGE, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 3540189 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE CADSTREAM |
| Generic Name | IMAGING PROCESSING SYSTEM |
| Product Code | LLZ |
| Date Received | 2020-03-25 |
| Model Number | 6.0.1.933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |