MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-30 for PURITAN BENNETT manufactured by Covidien Llc.
[29929491]
Patient Sequence No: 1, Text Type: N, H10
[29929492]
Patient went to have to ct scan from er. The patient was manually ventilated to ct scan. Brought 840, set up 840 and put patient on vent. After ct scan was done, the patient coded and we started manually ventilating the patient. Got pulse back and returned to room and when respiratory therapist went to turn on the vent in room 8, it said ventilator malfunction. Kept manually ventilating patient until new vent was brought to room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5191040 |
| MDR Report Key | 5191040 |
| Date Received | 2015-10-30 |
| Date of Report | 2015-10-23 |
| Date of Event | 2015-09-29 |
| Report Date | 2015-10-23 |
| Date Reported to FDA | 2015-10-23 |
| Date Reported to Mfgr | 2015-10-23 |
| Date Added to Maude | 2015-10-30 |
| 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 | PURITAN BENNETT |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2015-10-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD, MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-30 |