NEO-FIT NEONATAL ENDOTRAC 42-2540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for NEO-FIT NEONATAL ENDOTRAC 42-2540 manufactured by Coopersurgical, Inc..

Event Text Entries

[136613275] Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. Reference e-complaint-(b)(4).
Patient Sequence No: 1, Text Type: N, H10


[136613276] Ref e-complaint-(b)(4). Vent alarmed low min. Volume patient desaturation no sensor pick up bradycardia -bagged- no etl o2. Please note additional complaints also filed for reported condition. In all of the events, this is varied. Some happened outside of any event or procedure and with a sleeping patient laying supine in bed. Some occurred with vomiting, bathing, kangaroo care, before, during, or after these procedures. Tube at different marking at gum or lip, desaturation, tube visually moving, ventilator alarms, not sensing breaths on ventilator, no chest movement. Patients required reintubation and received chest x-ray.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2019-00022
MDR Report Key8306498
Date Received2019-02-05
Date of Report2019-11-11
Date of Event2018-11-03
Date Mfgr Received2019-01-22
Device Manufacturer Date2018-10-26
Date Added to Maude2019-02-05
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 ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC,
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEO-FIT NEONATAL ENDOTRAC
Generic NameNEO-FIT
Product CodeJAY
Date Received2019-02-05
Model Number42-2540
Catalog Number42-2540
Lot Number247017
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-02-05

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