MEDI-FRIDGE MICRO REFRIDGERATOR MICRO-REFRIDGERATOR MF-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-30 for MEDI-FRIDGE MICRO REFRIDGERATOR MICRO-REFRIDGERATOR MF-1 manufactured by Medi-fridge.

Event Text Entries

[14872424] On daily check of narcotics counts in our ambulance, the supervising medic was alerted to a louder than normal fan noise coming from our medi-fridge, -micro-refrigerator with solid-state internal digital thermostat- at that point the inventory control seal from the device and removed the medication for eval. The medications-x4 2mg vials- were heated to the point of being unable to hold in a bare hand. This was immediately reported to the hospital pharmacy and the medications were replaced following our normal procedures. No patients were injured nor was any medication withheld from any patient as a result of this incident. The device was returned to the retail store diabetes and more, for replacement. Secondary to this incident, we have had every unit we purchased of this model fail on us without explainable cause and the company will only replace the units more of the same, refusing to provide a refund or even partial refund. To date we have returned 4 of the 5 units ordered and have removed them from service as they are unreliable and in our opinion dangerous to patients. This unit was one of 4 that ran 24-7 plugged into shore lines connected to the ambulance. All have failed in similar fashion with the exception of heating the medications. Dates of use: 2009. Diagnosis or reason for use: maintaining temperatures for medications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5010942
MDR Report Key1373651
Date Received2009-04-30
Date of Report2009-04-30
Date of Event2009-02-27
Date Added to Maude2009-05-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDI-FRIDGE MICRO REFRIDGERATOR
Generic NameMEDI-FRIDGE
Product CodeKSE
Date Received2009-04-30
Model NumberMICRO-REFRIDGERATOR
Catalog NumberMF-1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDI-FRIDGE
Manufacturer Address16238 RANCH ROAD 620 SUITE F184 AUSTIN TX 78717 US 78717


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-04-30

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