AMI PLUS APNEA MONITOR AMIPLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-28 for AMI PLUS APNEA MONITOR AMIPLUS manufactured by Cas Medical Systems Inc..

Event Text Entries

[2409551] The pt's mother reported that she found the child turning blue but that the apnea monitor did not audibly alarm, nor provide a visual indicator of apnea. Dates of use: (b)(6) 2012 - currently being used.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024510
MDR Report Key2481326
Date Received2012-02-28
Date of Report2012-02-28
Date of Event2012-02-08
Date Added to Maude2012-03-08
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAMI PLUS APNEA MONITOR
Generic NameAPENA MONITOR
Product CodeNPF
Date Received2012-02-28
Model NumberAMIPLUS
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCAS MEDICAL SYSTEMS INC.
Manufacturer Address44 EAST INDUSTRIAL ROAD BRANFORD CT 06405 US 06405


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2012-02-28

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