MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for PURITAN BENNETT EXPIRATORY BACTERIAL FILTER 840 VENTILATOR 10078444 REV B 4-070305-00 manufactured by Covidien Lp.
[100297533]
Patient Sequence No: 1, Text Type: N, H10
[100297534]
Pt on pb840 ventilator. Ventilator stopped working, reading no ventilation, severe occlusion. Rt (respiratory therapy) was at the bedside and immediately started bagging pt with ambu bag. Hr, and oxygen saturation remained stable during this time. Ventilator changed out to new pb840 ventilator. Biomed looked at the ventilator and determined that the expiratory filter was the problem, although it was a new filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7276738 |
| MDR Report Key | 7276738 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-02-04 |
| Report Date | 2018-02-13 |
| Date Reported to FDA | 2018-02-13 |
| Date Reported to Mfgr | 2018-02-13 |
| Date Added to Maude | 2018-02-16 |
| 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 | PURITAN BENNETT EXPIRATORY BACTERIAL FILTER 840 VENTILATOR |
| Generic Name | BACTERIAL FILTER, VENTILATOR |
| Product Code | CAH |
| Date Received | 2018-02-16 |
| Model Number | 10078444 REV B |
| Catalog Number | 4-070305-00 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-16 |