MAUDE MDR 9824032

MDR report key
9824032
Report number
9824032
Event key
0
Event type
3
Date of event
2020-02-28
Date received
2020-03-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Report source
U
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MASIMO RADICAL-7OXIMETERMASIMO CORPORATIONDQA9500* *

Patients

SequenceReceivedTreatmentOutcome
12020-03-120

Event Narratives

D

Patient 1

TERM C-SECTION WAS DELIVERED, PLACED ON RADIANT HEATED WARMER. INFANT RECEIVED POSITIVE PRESSURE VENTILATION (PPV) AND THE PULSE OX. WAS PLACED ON THE RIGHT WRIST PER NEONATAL RESUSCITATION (NRP) GUIDELINES. HOWEVER, THE MOSSIMO WAS ABLE TO READ THE HEARTRATE, BUT FAILED TO READ THE OXYGEN SATURATION. NURSE LEFT TO GRAB ANOTHER MOSSIMO LOCATED ON A NEARBY CART, BUT THAT MOSSIMO WAS ALSO ABLE TO READ THE HEART RATE BUT UNABLE TO READ THE OXYGEN SATURATION OF THE BABY. THIS NURSE AGAIN LEFT TO OBTAIN A YELLOW PORTABLE PULSE OXIMETER FROM A LABOR AND DELIVERY ROOM. THAT PULSE OXIMETER WAS FINALLY ABLE TO READ THE OXYGEN SATURATION OF THE BABY AT ~7 MINUTES OF AGE. NO HARM TO THE PATIENT.

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06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19

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