TRUSAT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for TRUSAT manufactured by Critikon De Mexico S. De R.l. De C.v..

Event Text Entries

[84995839] Ge healthcare's investigation is on-going at this time. A follow-up report will be submitted when the investigation is completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10


[84995840] Ge healthcare received information from an attorney alleging that while being used in a home environment, the trusat malfunctioned in some way in that it did not alarm when the patient stopped breathing or it indicated the patient had a pulse rate and was breathing when he was not. The patient subsequently expired. Ge healthcare? S investigation is ongoing, to attempt to determine the precise alleged malfunction of the device.
Patient Sequence No: 1, Text Type: D, B5


[96860951] Ge healthcare's investigation summary: the trusat was evaluated and tested in the presence of gehc, patient and customer (preferred homecare/lifecare solutions) representatives where it was initially noted that the device was providing a fault code for a non-operational sensor. It was also noted that the device still contained historical data which indicated that the trusat alarmed for low spo2 at the of the event (meaning the sensor was clearly operational when the event occurred). Furthermore, the trusat was tested for alarm functionality with a new (operational) sensor and was found to be alarming appropriately. It was observed during testing that the volume was set on it very lowest setting although it cannot be confirmed to what setting the volume was configured during the time of the event. The investigation for this event concluded there was no malfunction of the trusat device. The trusat complies with (b)(4) safety standards for alarms and (b)(4) safety standards with respect to volume settings.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008729547-2017-00010
MDR Report Key6845266
Date Received2017-09-06
Date of Report2017-11-01
Date of Event2015-11-30
Date Mfgr Received2017-10-27
Device Manufacturer Date1970-01-01
Date Added to Maude2017-09-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTOF SOOS
Manufacturer StreetMILWAUKEE
Manufacturer CityMILWAUKEE WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUSAT
Generic NameOXIMETER, EAR
Product CodeDPZ
Date Received2017-09-06
ID NumberUDI NOT REQUIRED
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCRITIKON DE MEXICO S. DE R.L. DE C.V.
Manufacturer AddressCALLE VALLE DEL CEDRO 1551 JUAREZ MX


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2017-09-06

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