MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for AIRCAST VF ELITE SYSTEM W/BATTERY 30B-B manufactured by Djo, Llc.
[181542411]
Initial reporter information: unknown. The unit has been discarded by the user facility. As such, no product evaluation can be performed.
Patient Sequence No: 1, Text Type: N, H10
[181542412]
It was reported that the "venaflow unit in or (operating room) began smoking and started on fire. The unit was plugged in at the time, but not in use on a patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2020-00006 |
| MDR Report Key | 9774031 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-01 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT ST. |
| Manufacturer City | VISTA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST VF ELITE SYSTEM W/BATTERY |
| Generic Name | SLEEVE, LIMB, COMPRESSIBLE |
| Product Code | JOW |
| Date Received | 2020-03-02 |
| Model Number | 30B-B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |