MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for BLENDER 03800A manufactured by Carefusion Corporation.
[145760641]
While setting up infant on high frequency oscillatory ventilator (hfov) therapist noted that patient was desating while on 100% o2. After troubleshooting and adjustments the therapist traced the o2 hose and determined the o2 blender hose was mis-connected on the hfov. The blender did not give notice of the mis-connection by alarming. Blender replaced and o2 sat readings rose on infant. Infant able to maintain o2 sat of 88 with fio2 set at 23%-28%. Blender removed and sent to biomedical for inspection. Bme inspection of the blender note that the alarm "whistle" cap was defective not allowing blender to alarm when just one gas was connected. Bme replaced alarm cap and blender was able to alarm on air or o2 hose disconnect. Biomedical to schedule blender for overhaul.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8631095 |
| MDR Report Key | 8631095 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-14 |
| Report Date | 2019-05-09 |
| Date Reported to FDA | 2019-05-09 |
| Date Reported to Mfgr | 2019-05-22 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-05-22 |
| Model Number | 03800A |
| Catalog Number | 03800A |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORPORATION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |