MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-14 for * MP3008 manufactured by Micropace Pty. Ltd..
[16304911]
The patient was scheduled for an electrophysiology study / atrial fibrillation radiofrequency ablation. The micro-pace system would not boot up so the case had to be cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3904746 |
| MDR Report Key | 3904746 |
| Date Received | 2014-05-14 |
| Date of Report | 2014-05-14 |
| Date of Event | 2014-05-14 |
| Report Date | 2014-05-14 |
| Date Reported to FDA | 2014-05-14 |
| Date Reported to Mfgr | 2014-07-01 |
| Date Added to Maude | 2014-07-01 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2014-05-14 |
| Returned To Mfg | 2014-05-14 |
| Model Number | MP3008 |
| Catalog Number | MP3008 |
| Lot Number | 025, SN/754 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPACE PTY. LTD. |
| Manufacturer Address | 3205 W WARNER AVE SANTA ANA CA 92704 US 92704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-14 |