MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-15 for BLOOM STIMULATOR DTU-215B 206276G manufactured by Fischer Medical Technologies Llc.
[20412261]
Ep lab located on hospital site had a patient go into ventricular fibrillation (vf). The procedure was an ep study evaluation for a possible ablation. Patient was stated to be okay. Dec mode was not working properly. S3 mode - timing was set at 600ms then changed to 470ms, but pacing jumped to 210ms abruptly and induced vf. Possible use error. They noted that they use the unit all the time and it is their only bloom unit. Did not receive additional information with indication of vf until (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006188092-2011-00002 |
| MDR Report Key | 2392015 |
| Report Source | 05,06 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-12-14 |
| Date of Event | 2011-11-03 |
| Date Mfgr Received | 2011-11-28 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RONALD SHORES, PRES. |
| Manufacturer Street | 325 INTERLOCKEN PARKWAY BLDG. C |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3032428079 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOM STIMULATOR |
| Generic Name | STIMULATOR FOR ELECTROPHYSIOLOGY |
| Product Code | JOQ |
| Date Received | 2011-12-15 |
| Returned To Mfg | 2011-11-28 |
| Model Number | DTU-215B |
| Catalog Number | 206276G |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISCHER MEDICAL TECHNOLOGIES LLC |
| Manufacturer Address | BROOMFIELD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-15 |