MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-31 for VENTIALARM II 5622 NA manufactured by Hudson Rci.
[130851]
At 12:50 pm rn charge nurse entered pt's room. Pt was dusky in color and without vital signs. Ventilator and alarms not sounding. Ventilator circuit observed to be disconnected from trach, ventilator producing air however pressure alarm did not sound. Circuit reconnected to trach, then removed to initiate manual ventilation and cpr. After circuit disconnected for cpr alarms sounded in approx 5 seconds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 221768 |
| MDR Report Key | 221768 |
| Date Received | 1999-03-31 |
| Date of Report | 1999-03-01 |
| Date of Event | 1999-02-19 |
| Date Facility Aware | 1999-03-05 |
| Report Date | 1999-03-24 |
| Date Added to Maude | 1999-05-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTIALARM II |
| Generic Name | EXTERNAL VENTILATOR ALARM |
| Product Code | CAP |
| Date Received | 1999-03-31 |
| Model Number | 5622 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4.6 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 215065 |
| Manufacturer | HUDSON RCI |
| Manufacturer Address | 27711 DIAZ RD PO BOX 9020 TEMECULA CA 925899020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1999-03-31 |