MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-10 for STENTOR PACS manufactured by Philips, Stentor.
[22231646]
The pt had had prior intracranial neurosurgery for brain cancer. The pt underwent interval brain mris to assess interval change, if any. When an mri of the brain was performed for new onset aphasia, the pacs device brought up a prior mri for comparison which was performed more than a year prior and was more ancient than the past three. Thus, the analysis by the radiologist was flawed, putting the pt at risk of mis-diagnosis and clinical error in treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021724 |
| MDR Report Key | 2213259 |
| Date Received | 2011-08-10 |
| Date of Report | 2011-08-10 |
| Date of Event | 2011-07-25 |
| Date Added to Maude | 2011-08-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENTOR PACS |
| Generic Name | STENTOR PACS |
| Product Code | LMD |
| Date Received | 2011-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS, STENTOR |
| Manufacturer Address | SAN FRANCISCO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2011-08-10 |