MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-02-13 for BERNOULLI MANAGEMENT SYSTEM X3002489 manufactured by Cardiopulmonary Corp.
[19986166]
It was reported to covidien that the dell cpu on 6 west locked up. The cpu will not complete p. O. S. T. And allow for patient monitoring. When the system went down, the nurses opened the doors to the patient rooms and turned up the alarm volume on the nellcor devices. Each nellcor device functioned properly. There was no patient injury or adverse event.
Patient Sequence No: 1, Text Type: D, B5
[20291408]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00145 |
| MDR Report Key | 4517800 |
| Report Source | 06,07 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-01-19 |
| Date Added to Maude | 2015-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BRAXTON |
| Manufacturer Street | 6135 GUNBARREL AVE. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3038768909 |
| Manufacturer G1 | CARDIOPULMONARY CORP |
| Manufacturer Street | 200 CASCADE BLVD |
| Manufacturer City | MILFORD CT 06460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERNOULLI MANAGEMENT SYSTEM |
| Generic Name | OXINET III AND LIFEGARD VUE |
| Product Code | MOD |
| Date Received | 2015-02-13 |
| Model Number | X3002489 |
| Catalog Number | X3002489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOPULMONARY CORP |
| Manufacturer Address | 200 CASCADE BLVD MILFORD CT 06460 US 06460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-13 |