MPS 2 CONSOLE 5201260

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for MPS 2 CONSOLE 5201260 manufactured by Quest Medical, Inc..

Event Text Entries

[137860798] The console will be evaluated when it is received and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[137860799] A report was received regarding an alleged issue encountered during use of the mps console. The report states that during a case, the console gave the error message "internal error". The console was power cycled to clear the error and the case was completed without any patient complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2019-00005
MDR Report Key8324171
Date Received2019-02-08
Date of Report2019-02-08
Date Mfgr Received2019-01-11
Date Added to Maude2019-02-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTOSAN ONOSODE
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723326338
Manufacturer G1QUEST MEDICAL, INC.
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal Code75002
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMPS 2 CONSOLE
Generic NameCPBP HEAT EXHANGER
Product CodeDTR
Date Received2019-02-08
Model Number5201260
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-08

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