MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for CAREFUSION 3100A - UPGRADE 768901 manufactured by Carefusion.
[38148956]
The carefusion fse was unable to duplicate complaint. He checked with his circuit and performed a circuit calibration and performance checkout. Paw=21, deltap=60 w/o humidifier. All is ok.
Patient Sequence No: 1, Text Type: N, H10
[38148957]
The following description of the event was received from carefusion fse on (b)(6) 2014. The carefusion fse was onsite and the reported that they could not pressurize the unit above 33 cm. There was no indication that the patient was harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-02852 |
| MDR Report Key | 5413931 |
| Date Received | 2016-02-05 |
| Date of Report | 2014-01-29 |
| Date of Event | 2014-01-29 |
| Date Mfgr Received | 2014-01-28 |
| Device Manufacturer Date | 1998-06-01 |
| Date Added to Maude | 2016-02-05 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARSHALL THOMPSON |
| Manufacturer Phone | 7607787307 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAREFUSION |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | FSZ |
| Date Received | 2016-02-05 |
| Model Number | 3100A - UPGRADE |
| Catalog Number | 768901 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-05 |