MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-05-01 for CIRRUS ECT GAMMA CAMERA NA manufactured by Philips Medical Systems (cleveland), Inc..
[18516427]
Issue was reported to philips on (b)(6)2009. A third party service group has reported the following: the safety circuitry on the cirrus ect gama camera was bypassed by a previous service vendor. No serious injury to pt or operator was reported.
Patient Sequence No: 1, Text Type: D, B5
[18695156]
Philips has confirmed with the site that the system is no longer in use and that the camera is scheduled to be removed. A new camera will be installed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916556-2009-00003 |
| MDR Report Key | 1378376 |
| Report Source | 99 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-04-02 |
| Date of Event | 2009-02-10 |
| Date Mfgr Received | 2009-04-02 |
| Device Manufacturer Date | 1994-03-01 |
| Date Added to Maude | 2010-09-29 |
| 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 | ROBERT PHILLIPS |
| Manufacturer Street | 595 MINER ROAD |
| Manufacturer City | CLEVLAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRRUS ECT GAMMA CAMERA |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IYX |
| Date Received | 2009-05-01 |
| Model Number | ECT |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 3860 N. FIRST ST SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-01 |