MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for VITAL SIGNS ADULT BREATHING CIRCUIT A5U510X4 manufactured by Carefusion.
[118554864]
During the daily anesthesia automated performance testing, the anesthesia machine failed breathing circuit leak test. Troubleshooting by the bio-medical engineering technician (bmet) noted that when 3 liter breathing bag was connected during leak test the system would fail pre-operative leak test. The bmet replaced the breathing bag with a silicon test plug and the leak self test passed. When 3 liter bag was placed on separate 22mm bag arm connector the bmet validated that the bag connector would not hold pressure and would leak. Several breathing bags were tested with similar results, some with more significant leaks than others. The breathing bags are a component part of a single patient use anesthesia breathing circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7824005 |
| MDR Report Key | 7824005 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-08-15 |
| Report Date | 2018-08-20 |
| Date Reported to FDA | 2018-08-20 |
| Date Reported to Mfgr | 2018-08-28 |
| Date Added to Maude | 2018-08-28 |
| 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 | 0 |
| Brand Name | VITAL SIGNS ADULT BREATHING CIRCUIT |
| Generic Name | ANESTHESIA BREATHING CIRCUIT |
| Product Code | BSJ |
| Date Received | 2018-08-28 |
| Model Number | A5U510X4 |
| Catalog Number | A5U510X4 |
| Lot Number | 0004033682 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| 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 | 2018-08-28 |