MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-04-14 for INGENUITY TF PET/MR 882380 manufactured by Philips Medical Systems(cleveland), Inc..
[5638853]
With the info provided, the customer reported that after performing a clinical pet/mr brain scan, the 256x256 (2mm) and the 576x576 (4mm) attenuation maps (mu-map) data was misaligned. The 4mm attenuation map was shifted to the left and up about 1 voxel (2 to 4 mm). This resulted in the reconstructions to have a left to right difference (profile ramp) in pet activity concentration and suv valve. The clinical product specialist stated that there has been no report of harm or image misinterpretation to a pt as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[13134144]
(b)(4). We will file a follow up mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32488253]
(b)(4). Initial mdr mailed on april 14, 2015. On (b)(6) 2015, the customer reported that after performing a clinical pet/mr brain scan, the 256x256 (2mm) and the 576x576 (4mm) attenuation maps (mu-map) data was misaligned. The 4mm attenuation map was shifted to the left and up about 1 voxel (2 to 4 mm). This resulted in the reconstructions to have a left to right difference (profile ramp) in pet activity concentration and suv value. The clinical product specialist stated that there has been no report of harm or image misinterpretation to a patient as a result of this issue. Further review of the information provided by the customer has determined that the variance is within the acceptable tolerance as defined in the following mitigation: gemsrs4158: after software calibration, the maximum error between the position of a point in the mr slice and the position of the corresponding point in the pet field of view shall be less than 4 mm. The observed variance was within the 4mm tolerance and therefore no correction was applicable for this issue. No further cause determination is applicable because further investigation of the information provided by the customer has determined that the variance is within the acceptable tolerance as defined in gemsrs4158: after software calibration, the maximum error between the position of a point in the mr slice and the position of the corresponding point in the pet field of view shall be less than 4 mm.
Patient Sequence No: 1, Text Type: N, H10
[32488255]
With the information provided, the customer reported that after performing a clinical pet/mr brain scan, the 256x256 (2mm) and the 576x576 (4mm) attenuation maps (mu-map) data was misaligned. The 4mm attenuation map was shifted to the left and up about 1 voxel (2 to 4 mm). This resulted in the reconstructions to have a left to right difference (profile ramp) in pet activity concentration and suv value. The clinical product specialist stated that there has been no report of harm or image misinterpretation to a patient as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525965-2015-00101 |
| MDR Report Key | 4698412 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-04-14 |
| Date of Report | 2015-03-16 |
| Date Mfgr Received | 2015-03-16 |
| Date Added to Maude | 2015-05-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAN BROWN |
| Manufacturer Street | 595 MINER RD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833000 |
| Manufacturer G1 | PHILLIPS MEDICAL SYSTEMS |
| Manufacturer Street | 595 MINER RD MR TRAINING DEPARTMENT |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INGENUITY TF PET/MR |
| Generic Name | TOMOGRAPHIC IMAGER COMBINING EMISSION CT WITH NUCLEAR MR |
| Product Code | OUO |
| Date Received | 2015-04-14 |
| Model Number | 882380 |
| Catalog Number | 882380 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-04-14 |