MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for AIRLIFE RT509-852 manufactured by Carefusion 2200, Inc..
[25118452]
Patient Sequence No: 1, Text Type: N, H10
[25118453]
The staff went to reposition the ventilator circuit and it ripped a hole in the expiratory limb. The hole was caused by the circuit melting the temp probe wire and it came apart when moved. We have seen this type of event before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5060203 |
| MDR Report Key | 5060203 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-08-03 |
| Report Date | 2015-08-11 |
| Date Reported to FDA | 2015-08-11 |
| Date Reported to Mfgr | 2015-08-11 |
| Date Added to Maude | 2015-09-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | AIRLIFE |
| Generic Name | VENTILATOR BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-09-08 |
| Catalog Number | RT509-852 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |