MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-01 for BLOOM * PN106276G manufactured by Fischer Medical.
[2729996]
Patient was on the table prepped and draped with sheaths and catheters placed by the doctor. We were unable to pace. The bloom was not completely communicating with our with our ge system. Therefore we were unable to complete the study. No harm to the patient. ======================manufacturer response for electrophsiology bloom, electrophysiology bloom (per site reporter). ======================biomed evaluated and repaired the device. The bloom stimulator is now functioning appropriately. Ce# 824457-wo # 612701 trouble shot problem, found connector from bloom stimulator was partially disconnected. Reseated connector plug in to bloom stimulator, sys ops. Tested good and returned to use after verbal release from risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2617893 |
| MDR Report Key | 2617893 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-05-01 |
| Report Date | 2012-06-01 |
| Date Reported to FDA | 2012-06-01 |
| Date Added to Maude | 2012-06-15 |
| 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 | 0 |
| 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 | BLOOM |
| Generic Name | GENERATOR, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2012-06-01 |
| Model Number | * |
| Catalog Number | PN106276G |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISCHER MEDICAL |
| Manufacturer Address | 325 INTERLOCKEN PKWY BLDG C BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-01 |