E-SCAIO E-SCAIO-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-03 for E-SCAIO E-SCAIO-00 manufactured by Ge Healthcare.

Event Text Entries

[116293356] Etco2 reader displayed error message, machine would not pick up etco2 or et for inhalation agent. Machine had passed check before case. Also, daily check.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078877
MDR Report Key7752551
Date Received2018-08-03
Date of Report2018-08-01
Date of Event2018-07-21
Date Added to Maude2018-08-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameE-SCAIO
Generic NameANALYZER, GAS, OXYGEN, GASEOUS
Product CodeCCL
Date Received2018-08-03
Model NumberE-SCAIO-00
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE
Manufacturer AddressWAUWATOSA WI 53226 US 53226


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-03

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