MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-16 for PRISM NUCLEAR GAMMA CAMERA SYSTEM 453566512911 88201 manufactured by Philips Medical Systems (cleveland), Inc..
[18490105]
A customer reported a monitor failure at the gantry control which was followed by smoke and a burning smell from the capacitor in the power supply. The defective power supply has been determined to be responsible for the smoke development. A new power supply has been ordered for replacement. The fire dept was called.
Patient Sequence No: 1, Text Type: D, B5
[18698728]
Note: we have not completed our investigation of this event. We will file a follow-up mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2010-00037 |
| MDR Report Key | 1942474 |
| Report Source | 05,06 |
| Date Received | 2010-11-16 |
| Date of Report | 2010-10-18 |
| Date Mfgr Received | 2010-10-18 |
| Date Added to Maude | 2011-08-10 |
| 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 | ELIZABETH MCLAIN |
| Manufacturer Street | 5520 NOBEL DR. |
| Manufacturer City | FITCHBURG WI 53711 |
| Manufacturer Country | US |
| Manufacturer Postal | 53711 |
| Manufacturer Phone | 6082886948 |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44143 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM NUCLEAR GAMMA CAMERA SYSTEM |
| Product Code | IYX |
| Date Received | 2010-11-16 |
| Model Number | 453566512911 |
| Catalog Number | 88201 |
| 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 | 2010-11-16 |