MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for FLEXICARE FL - 9000U RESPIRATORY HUMIDIFIER BASE FL-9000U manufactured by Flexicare Usa.
[83507701]
Respiratory therapist discovered vent circuit melted. Vent circuit was connected to the pt at the time of discovery. Pt was off the ventilator. The vent circuit was on the bed. The heater was on but the ventilator was off. We are unsure of this is due to the humidifier or the circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071737 |
| MDR Report Key | 6812590 |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-08-09 |
| Date Added to Maude | 2017-08-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXICARE FL - 9000U RESPIRATORY HUMIDIFIER BASE |
| Generic Name | RES. HUMIDIFIER BASE |
| Product Code | BTT |
| Date Received | 2017-08-23 |
| Model Number | FL-9000U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLEXICARE USA |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Brand Name | CAREFUSION |
| Generic Name | SINGLE PATIENT USE CIRCUIT |
| Product Code | MOD |
| Date Received | 2017-08-23 |
| Lot Number | 0001130368 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-23 |