BERNOULLI MANAGEMENT SYSTEM 3274

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2936999-2015-00210
MDR Report Key4587814
Report Source05,06
Date Received2015-03-10
Date of Report2015-02-24
Date of Event2014-09-17
Date Mfgr Received2015-07-10
Date Added to Maude2015-04-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTHOM MCNAMARA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524811
Manufacturer G1CARDIOPULMONARY CORP.
Manufacturer Street200 CASCADE BLVD.
Manufacturer CityMILFORD CT 06480
Manufacturer CountryUS
Manufacturer Postal Code06480
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBERNOULLI MANAGEMENT SYSTEM
Generic NameOXINET III AND LIFEGARD VUE
Product CodeMOD
Date Received2015-03-10
Returned To Mfg2014-09-26
Model Number3274
Catalog Number3274
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARDIOPULMONARY CORP.
Manufacturer Address200 CASCADE BLVD. MILFORD CT 06480 US 06480


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-10

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