TEMP PUMP TEMPERATURE TP500C NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-27 for TEMP PUMP TEMPERATURE TP500C NA manufactured by Stryker Corp Dba Gaymar.

Event Text Entries

[2021072] It was reported the unit was not functioning properly. Upon eval, evidence of fluid ingress was detected and the well thermostat and sensor bracket were corroded. No pt involvement or adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1313850-2011-00123
MDR Report Key2119698
Report Source06
Date Received2011-05-27
Date of Report2011-04-29
Date of Event2011-04-29
Date Mfgr Received2011-04-29
Device Manufacturer Date2008-02-15
Date Added to Maude2011-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactRENATA SILA
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693896689
Manufacturer G1STRYKER CORP DBA GAYMAR
Manufacturer Street10 CENTRE DR.
Manufacturer CityORCHARD PARK NY 14127
Manufacturer CountryUS
Manufacturer Postal Code14127
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTEMP PUMP TEMPERATURE
Generic NamePUMP
Product CodeFOH
Date Received2011-05-27
Model NumberTP500C
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CORP DBA GAYMAR
Manufacturer AddressORCHARD PARK NY 14127 US 14127


Patients

Patient NumberTreatmentOutcomeDate
10 2011-05-27

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