MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for VITAL SIGNS manufactured by Carefusion.
[103311049]
Patient Sequence No: 1, Text Type: N, H10
[103311050]
When preparing and setting up anesthesia breathing circuit for next case, it was noted that the co2 nipple attachment on the elbow of the adult breathing circuit did not have a hole in it for flow and monitoring. It is closed, no opening. Therefore, device would not function properly for anesthesia if needed to use. All of the said lot number have been pulled from stock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7365524 |
| MDR Report Key | 7365524 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-01-16 |
| Report Date | 2018-01-24 |
| Date Reported to FDA | 2018-01-24 |
| Date Reported to Mfgr | 2018-01-24 |
| Date Added to Maude | 2018-03-23 |
| 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 |
| 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 | VITAL SIGNS |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-03-23 |
| Lot Number | 0001189010 |
| ID Number | A46X29XX |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |