S3 BUBBLE DETECTOR 23-07-50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-07 for S3 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.

Event Text Entries

[76971715] Patient information was not provided. Livanova (b)(4) manufactures the s3 bubble detector. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative confirmed the reported issue and replaced the s3 bubble detector. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is on-going. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[76971716] Livanova (b)(4) received a report that the s3 bubble detector had deflated bladders and failed twice during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611109-2017-00394
MDR Report Key6620653
Report SourceHEALTH PROFESSIONAL
Date Received2017-06-07
Date of Report2017-10-23
Date of Event2017-05-11
Date Mfgr Received2017-09-29
Device Manufacturer Date2013-09-12
Date Added to Maude2017-06-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOAN CEASAR
Manufacturer Street14401 W. 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer Phone2812287260
Manufacturer G1LIVANOVA DEUTSCHLAND
Manufacturer StreetLINDBERGHSTR. 25
Manufacturer CityMUNICH 80939
Manufacturer CountryGM
Manufacturer Postal Code80939
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS3 BUBBLE DETECTOR
Generic NameMONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
Product CodeKRL
Date Received2017-06-07
Model Number23-07-50
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA DEUTSCHLAND
Manufacturer AddressLINDBERGHSTR. 25 MUNICH, 80939 GM 80939


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-07

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