MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ESPIRIT V1000 56625818 989805611721 manufactured by Philips North America Llc.
[185926569]
No harm to pt, vent #17 alarmed with error code#1014. First rt manually ventilated pt while second rt obtained a replacement ventilator. Ventilator #17 powered down by itself. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093980 |
| MDR Report Key | 9903113 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-19 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ESPIRIT V1000 |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBK |
| Date Received | 2020-03-30 |
| Model Number | 56625818 |
| Catalog Number | 989805611721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS NORTH AMERICA LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |