MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-03-11 for ULTEGRA RPFA-TRAP 85013 manufactured by Accumetrics.
[22171955]
The ultegra analyzer, its printer, and the printer power supply were involved in a fire in the hosp's cardiac catheterization lab. The fire occurred after hours (approximately 9-10 pm), when the lab was not in use. No hosp personnel or pts were present at the time of the fire. Hosp personnel were alerted by an alarm, and the fire was extinguished. The fire was limited to a small area where the ultegra, printer, testing supplies, and another small instrument were located. Smoke was observed in the cath lab. No one was injured by the fire or smoke. It is not known how the fire started, because no one was present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031760-2005-00001 |
| MDR Report Key | 583568 |
| Report Source | 05 |
| Date Received | 2005-03-11 |
| Date of Event | 2005-01-25 |
| Date Mfgr Received | 2005-02-09 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-03-23 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BARBARA STEVENS |
| Manufacturer Street | 3985 SORRENTO VALLEY BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584048281 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTEGRA RPFA-TRAP |
| Generic Name | PLATELET FUNCTION ASSAY |
| Product Code | JOZ |
| Date Received | 2005-03-11 |
| Returned To Mfg | 2005-03-02 |
| Model Number | NA |
| Catalog Number | 85013 |
| Lot Number | NA |
| ID Number | 29001, PRINTER PN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 573396 |
| Manufacturer | ACCUMETRICS |
| Manufacturer Address | * SAN DIEGO CA 92121 US |
| Baseline Brand Name | ULTEGRA RPFA-TRAP |
| Baseline Generic Name | PLATELET FUNCTION ASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | 85013 |
| Baseline ID | 29001, PRINTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-11 |