MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for BREATHING CIRCUIT manufactured by .
[67565132]
Patient Sequence No: 1, Text Type: N, H10
[67565193]
Potential for harm: cardiac/respiratory arrest, rt does not have a pediatric ventilation circuit. Potentially extremely dangerous
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6332563 |
| MDR Report Key | 6332563 |
| Date Received | 2017-02-15 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-01-11 |
| Report Date | 2015-09-15 |
| Date Reported to FDA | 2015-09-15 |
| Date Reported to Mfgr | 2015-09-15 |
| Date Added to Maude | 2017-02-15 |
| 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 | 0 |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2017-02-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-15 |