MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-11-02 for AXIS GAMMA CAMERA 221037 882130 manufactured by Philips Medical Systems (cleveland), Inc..
[712734]
During morning set-up of the axis gamma camera, the customer began to smell smoke. The customer called the fire dept and they did a power shut down for the whole room. The fse evaluated the system and discovered the current motor controller was not operational and created too much friction, when the operator attempted to move the table. The part was replaced. No pts were in the room during the issue and all operating personnel were evacuated from the area. No serious injury to pt or operator occurred.
Patient Sequence No: 1, Text Type: D, B5
[8121295]
Add'l info: this mdr is being filed as an initial report. A final report will follow once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2007-00026 |
| MDR Report Key | 937627 |
| Report Source | 06,07 |
| Date Received | 2007-11-02 |
| Date of Report | 2007-11-02 |
| Date of Event | 2007-10-09 |
| Date Mfgr Received | 2007-10-09 |
| Date Added to Maude | 2007-12-27 |
| 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 | MELINDA NOVATNY |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404834255 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIS GAMMA CAMERA |
| Generic Name | AXIS |
| Product Code | IYX |
| Date Received | 2007-11-02 |
| Model Number | 221037 |
| Catalog Number | 882130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 934776 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-02 |