MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-25 for PHILIPS FORTE manufactured by Philips Medical Systems.
[1878403]
Pt was injected at peak stress as power protocol in the stress lab and was accompanied to the imaging room for immediate scintigraphy. Shortly after image acquisition had begun, the scintallation camera ((b)(4)) stopped and the system displayed an error: the collision surface on bonnet 2 is in open condition. System is not safe to use, cancel any studies in progress. If necessary, disengage table pins or use table cable release and manually extract pt. System is now down, call your field service engineer. The pt was safely extracted from the gantry. But as stress thallium imaging must begin no more than fifteen minutes after injection, the study could not be continued on another camera. The field service engineer was called and traced the problem to two loose connections on the detector, replaced a sensor and tightened an access door. The engineer stayed to observe the camera in action and reports that no further abnormalities were evident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019977 |
| MDR Report Key | 2034832 |
| Date Received | 2011-03-25 |
| Date of Report | 2011-03-25 |
| Date of Event | 2011-03-23 |
| Date Added to Maude | 2011-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS FORTE |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2011-03-25 |
| Lot Number | 541373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | BRIARCLIFF NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-25 |