S3 BUBBLE DETECTOR 23-07-40

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 2018-06-04 for S3 BUBBLE DETECTOR 23-07-40 manufactured by Livanova Deutschland.

Event Text Entries

[110053302] Patient information was not provided. Livanova (b)(4) manufactures the s3 bubble detector. The incident occurred in (b)(6). The bubble detector has been requested for return to livanova (b)(4) for investigation. 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


[110053303] Livanova (b)(4) received a report that an s3 bubble detector did not alarm as expected post-procedure. The device failed to alarm even if only air was present in the transmission line. The customer reported that the pump stopped as expected and no air was delivered to the patient. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611109-2018-01020
MDR Report Key7567743
Report SourceHEALTH PROFESSIONAL
Date Received2018-06-04
Date of Report2018-06-26
Date of Event2018-05-03
Date Mfgr Received2018-06-07
Device Manufacturer Date2006-07-18
Date Added to Maude2018-06-04
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 Received2018-06-04
Model Number23-07-40
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 2018-06-04

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