MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-18 for STENTOR PACS manufactured by Philips.
[1646980]
Pt with chief complaint of shortness of breath. Cta of chest, abdomen, pelvis was ordered. Report sent was that of a mri of the spine, despite the ordered test being listed on the report as "cta chest abdomen pelvis". Misidentification is the general category of defect though there is commingling of data divergent with the listed test. It is unk by this reporter if this was part of a recursive process affecting innumerable pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015614 |
| MDR Report Key | 1664447 |
| Date Received | 2010-04-18 |
| Date of Report | 2010-04-18 |
| Date of Event | 2009-10-06 |
| Date Added to Maude | 2010-04-26 |
| 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 | PACS |
| Product Code | LMD |
| Date Received | 2010-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | FOSTER CITY CA US |
| Brand Name | SOARIAN EMR |
| Generic Name | EMR |
| Product Code | NSX |
| Date Received | 2010-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-04-18 |