MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-12-11 for INGENUITY TF PET/MR 882380 manufactured by Philips Medical Systems(cleveland), Inc..
[4128433]
The customer reported a left to right misalignment with pet reconstructed images. The images appear diagnostic and show a finding that is typical with patients with memory disorder. After reconstructing data again, the finding disappears. Therefore, the initial reconstruction has left to false positive results in more than one patient. The issue was discovered during a research protocol, when the scanning of healthy volunteers presented with the same findings as those patients with known memory disorders. The healthy volunteers have undergone a series of neuropsychological tests and have been determined healthy. The discrepancy between the imaging findings and neuropsychological results has led to further investigation and the site is currently reviewing patient data.
Patient Sequence No: 1, Text Type: D, B5
[11458289]
Note: we have not completed our investigation of this event. We will file a follow-up mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2013-00440 |
| MDR Report Key | 3525443 |
| Report Source | 05,06,07 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-11-25 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2014-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KUMUDINI CARTER |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INGENUITY TF PET/MR |
| Product Code | OUO |
| Date Received | 2013-12-11 |
| Model Number | 882380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-11 |