MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-12 for BLOOM STIMULATOR DTU-215B 206276H manufactured by Fischer Medical Technologies Llc.
[2447990]
Ep lab located on hosp site had a pt go into ventricular tachycardia (vtac). Took pt off of the bloom and ge mac lab equipment and utilized a manual pacemaker. The procedure was an ep study eval for a possible ablation or defibrillator implantation. The boom and ge mac lab equipment was initially being used during the case until the dr began trying different rates and then the pt went into vtac, they used a hand held pacemaker to manually stabilize the pt and the sinus rhythm was restored. Pt was stated to be okay and a defibrillator was not necessary/or used. S1 intervals were initially set at 600 ms, then were changed to 590 ms (pause in stimulus) then they got an unexpected burst of 50 50 ms pulses. Possible use error. They noted that they have been using this unit constantly for 2 1/2 years and this was the first time they have encountered an issue. They have three labs with three bloom units and use them on a daily basis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006188092-2011-00001 |
| MDR Report Key | 2375846 |
| Report Source | 05,06 |
| Date Received | 2011-12-12 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-16 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-07-23 |
| 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 PKWY 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 | 2011-12-12 |
| Returned To Mfg | 2011-12-02 |
| Model Number | DTU-215B |
| Catalog Number | 206276H |
| 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 | 2011-12-12 |