MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-10 for BERNOULLI MANAGEMENT SYSTEM 3274 manufactured by Cardiopulmonary Corp..
[5339620]
It was reported that the oxinet iii alarm management system locked -up with a system loading message. Patients were being monitored by the oximeters in the rooms. There was no report of patient serious injury or death as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12982561]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25399554]
Covidien reference: (b)(4). The device was returned for investigation and the reported malfunction was verified. A database error was identified and the latest software was loaded to resolve the issue. The device then passed testing and was placed back in service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00210 |
| MDR Report Key | 4587814 |
| Report Source | 05,06 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-24 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2015-07-10 |
| Date Added to Maude | 2015-04-09 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | CARDIOPULMONARY CORP. |
| Manufacturer Street | 200 CASCADE BLVD. |
| Manufacturer City | MILFORD CT 06480 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06480 |
| 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 | 2015-03-10 |
| Returned To Mfg | 2014-09-26 |
| Model Number | 3274 |
| Catalog Number | 3274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOPULMONARY CORP. |
| Manufacturer Address | 200 CASCADE BLVD. MILFORD CT 06480 US 06480 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-10 |