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 2018-12-18 for S3 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.

Event Text Entries

[130708449] Patient information was not provided. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova deutschland manufactures the s3 bubble detector. The incident occurred in (b)(4). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[130708450] Livanova deutschland received a report that the sensitivity of a s3 bubble detector became unstable and error message occurred. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611109-2018-01410
MDR Report Key8173123
Report SourceHEALTH PROFESSIONAL
Date Received2018-12-18
Date of Report2019-02-13
Date of Event2018-11-20
Date Mfgr Received2019-01-22
Date Added to Maude2018-12-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNJEMILE CRAWLEY
Manufacturer Street14401 W. 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer Phone2812287575
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 Received2018-12-18
Model Number23-07-50
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA DEUTSCHLAND
Manufacturer AddressLINDBERGHSTR. 25 MUNICH US


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-18

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