MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-14 for PURITAN BENNETT 840 manufactured by Covidien Llc.
[28152383]
Patient Sequence No: 1, Text Type: N, H10
[28152385]
Ventilator inop alarm on unstable patient: apparent screen/gui malfunction, so screen was black. Took patient off and used ambu bag to ventilate the patient while the ventilator was taken out of service. The ventilator was taken out of service with circuit intact for biomed troubleshooting. Service request placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5147791 |
| MDR Report Key | 5147791 |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-20 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-14 |
| 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 | 2015-10-14 |
| Model Number | 840 |
| 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 | 1. Other | 2015-10-14 |