MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-28 for INGENUITY TF PET/MR 882380 manufactured by Philips Medical Systems(cleveland), Inc..
[2548512]
Philips received a customer complaint stating a photopenic artifact was detected through the lower lungs on the magnetic resonance attenuation corrected (mrac) image. The customer also noticed low uptake in the inferior wall of the heart that was also detected on the non-attenuation corrective (nac) images. The artifact is not present on the mr map or nac dataset.
Patient Sequence No: 1, Text Type: D, B5
[9670837]
(b)(4). There is a remote potential for false-negative interpretation in pts with neoplasm that could result in lack of treatment leading to the necessity for medical intervention to prevent permanent impairment. There was no report of harm to a pt in this case and the harm is not expected to occur due to trained interpreting physician recognizing image artifact, and default display of non-ac and attenuation map for comparison. Instructions for use includes review of non-attenuation correction images (459800153451 rev. B p18). This reported event is currently under investigation. A follow-up report will be sent when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2012-00004 |
| MDR Report Key | 2483586 |
| Report Source | 07 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-03 |
| Date of Event | 2012-01-24 |
| Date Mfgr Received | 2012-02-03 |
| Date Added to Maude | 2012-08-23 |
| 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 |
| 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 |
| Generic Name | INGENUITY TF PET/MR |
| Product Code | OUO |
| Date Received | 2012-02-28 |
| Model Number | 882380 |
| Catalog Number | 882380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-02-28 |