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 2014-03-03 for INGENUITY TF PET/MR 882380 manufactured by Philips Medical Systems(cleveland), Inc..
[16687234]
The customer was using a phantom to validate one of their protocols on their ingenuity tf pet/mr system, when they noticed the (digital imaging and communications in medicine) dicom header on the 'mr spectroscopy storage' of chemical shift imaging (csi) had an incorrect format to identify rows and columns. The customer also noticed that when the data was transferred to non-philips device and processed with dicom header info according to the dicom standard; the spectroscopic images would be transposed and image orientation would be mislabeled resulting in a wrong orientation of the csi data. A spectrum that is normally located at the top right hand corner was now located at the bottom left hand corner. There was no report of harm to a pt, bystander or trained professional as a result of the issue. The validation testing was all done using a phantom with no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[16712398]
(b)(4). Note: we have not completed our investigationi 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 | 1525965-2014-00038 |
| MDR Report Key | 3687404 |
| Report Source | 05,06,07 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-14 |
| Date Mfgr Received | 2014-02-14 |
| Date Added to Maude | 2014-05-12 |
| 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 | 2014-03-03 |
| Model Number | 882380 |
| Catalog Number | 882380 |
| Lot Number | NA |
| 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 | 2014-03-03 |