FDA.reportPublic FDA data

MAUDE MDR 9810747

MDR report key
9810747
Report number
9810747
Event key
0
Event type
3
Date of event
2020-02-25
Date received
2020-03-10
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GIRAFFE OMNIBED CARESTATIONINCUBATOR, NEONATALDATEX-OHMEDA, INCFMZCS1* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-100

Event Narratives#

D

Patient 1

DURING ROUTINE INSPECTIONS OF THE DATEX-OHMEDA/GE GIRAFFE OMNIBED CARE STATION INFANT INCUBATORS, WE HAVE STARTED NOTICING SMALL CRACKS ON THE SURFACE OF THE FOOT SECTION ACRYLIC PANEL (PLEASE SEE PICTURES ATTACHED). THE CRACKS ARE MOSTLY SEEN AROUND THE STRESS POINTS WHERE THE ACRYLIC IS MOLDED. THE CONCERN IS ABOUT FUTURE BREAKS ON THOSE AREAS IF THE CRACKS KEEPS DEVELOPING ONTO BIGGER DENTS. IT COULD CAUSE POSSIBLE INJURY TO USERS AND COULD BE A RISK TO PATIENTS. SO FAR, NO INJURIES OR INCIDENTS HAVE HAPPENED, WE ARE REPLACING THOSE ACRYLICS WITH NEW ONES, A PO (PURCHASE ORDER) TO GE WAS ISSUED FOR THE NEW PARTS.