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 2014-01-16 for INGENUITY TF PET/MR 882380 manufactured by Philips Medical Systems(cleveland), Inc..
[4092639]
The customer reported that during a test of an mri breast protocol with the new mammocoil on the philips pet/mri, a pt was positioned on the coil and the table was moved into the mri tunnel using the "travel to scanplane" button. During the movement of the table to the scanning position, the pt became trapped between the coil and the top of the bore. The pt indicated pain and was immediately removed from the bore. A few days later, the pt was diagnosed with a broken rib.
Patient Sequence No: 1, Text Type: D, B5
[11611077]
Note: we have not completed our investigation of this event. We will file a f/u mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2014-00014 |
| MDR Report Key | 3597167 |
| Report Source | 05,06,07 |
| Date Received | 2014-01-16 |
| Date of Report | 2014-01-07 |
| Date Mfgr Received | 2014-01-07 |
| Date Added to Maude | 2014-01-31 |
| 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 | 2014-01-16 |
| Model Number | 882380 |
| Lot Number | UNK |
| 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 | 2014-01-16 |