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 IRIX GAMMA CAMERA 211038 NA manufactured by Philips Medical Systems, Inc. (cleveland).
[732151]
During a service visit, the field service engineer installed the electro-craft shunt kit as an enhancement to the irix system. The first shunt component failed immediately after install. The second unit began to smoke and the system was shut dow. The shunt was removed. The system is currently operational. No pts were in the room during the issue. No serious injury to pt or operator occurred.
Patient Sequence No: 1, Text Type: D, B5
[8011805]
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 | 1525965-2007-00027 |
| MDR Report Key | 937629 |
| Report Source | 06,07 |
| Date Received | 2007-11-02 |
| Date of Report | 2007-11-02 |
| Date of Event | 2007-10-04 |
| Date Mfgr Received | 2007-10-04 |
| Device Manufacturer Date | 2000-03-29 |
| 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 | 3 |
| 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 | IRIX GAMMA CAMERA |
| Generic Name | IRIX |
| Product Code | IYX |
| Date Received | 2007-11-02 |
| Model Number | 211038 |
| Catalog Number | NA |
| 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 | 934735 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS, INC. (CLEVELAND) |
| Manufacturer Address | . CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-02 |