SECHRIST INDUSTRIES 35COB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for SECHRIST INDUSTRIES 35COB manufactured by Sechrist Industries, Inc..

Event Text Entries

[138769805] It was reported that pt on. 5ml of sweep prior to intubation. Increased flow and sweep for intubation. After intubation pt's o2 sats were stable; orders from physician to put sweep at. 5 and wean to cap as tolerated. Pt capped and abg pco2 elevated. Rechecked abg to verify results. When i went to increase sweep gas blender knob was difficult to turn. Sweep placed at 6l.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084865
MDR Report Key8416585
Date Received2019-03-12
Date of Report2019-03-11
Date of Event2019-03-08
Date Added to Maude2019-03-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameSECHRIST INDUSTRIES
Generic NameMIXER, BREATHING GASES, ANESTHESIA INHALATION
Product CodeBZR
Date Received2019-03-12
Model Number35COB
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerSECHRIST INDUSTRIES, INC.

Device Sequence Number: 1

Brand NameSECHRIST INDUSTRY
Generic NameMIXER, BREATHING GASES, ANESTHESIA INHALATION
Product CodeBZR
Date Received2019-03-12
Model Number35COB
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSECHRIST INDUSTRY, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-12

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