MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for PHILIPS MEDICAL FORTE manufactured by Philips Medical.
[41647624]
During a routine service performance, it was noted that movement on radius detector 2 was abnormal resulting in rough/loud movement. System was taken out of service at this time so no injury to patient or staff occurred. Further investigation indicated ball screw bearing/ball screw actuation causing the anomaly. The replacement of these components rectified the issue and the device was turned back over for patient use. The original equipment mfr ((b)(4)) completed the ball screw/bearing replacement on (b)(6) 2016. The unit has been operating within all specs since the repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061357 |
| MDR Report Key | 5537502 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-28 |
| Date of Event | 2016-01-12 |
| Date Added to Maude | 2016-03-31 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS MEDICAL |
| Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2016-03-28 |
| Model Number | FORTE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-28 |