MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-15 for PHOENIX manufactured by Gambro.
[5873751]
Dialysis machine fire: the machine had been in use with the pt for 2 hours before it began emitting a noxious odor and smoke. The nurse discontinued dialysis, unplugged the machine, and removed the machine from the room. There were no flames. The pt is on a ventilator so did not inhale/experience any effects of the smoke. Three employee that were in the room inhaled smoke and sought medical assessment; and they were returned to full duty. Early estimated relate the smoking to a solenoid valve in the machine's pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043115 |
| MDR Report Key | 4855553 |
| Date Received | 2015-06-15 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-06-12 |
| Date Added to Maude | 2015-06-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOENIX |
| Generic Name | DIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2015-06-15 |
| Model Number | PHOENIX |
| ID Number | EE# 58285 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-15 |