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 Number: MW5010942
• MDR Report Key: 1373651
• Date Received: 2009-04-30
• Date of Report: 2009-04-30
• Date of Event: 2009-02-27
• Date Added to Maude: 2009-05-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDI-FRIDGE MICRO REFRIDGERATOR
• Generic Name: MEDI-FRIDGE
• Product Code: KSE
• Date Received: 2009-04-30
• Model Number: MICRO-REFRIDGERATOR
• Catalog Number: MF-1
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDI-FRIDGE
• Manufacturer Address: 16238 RANCH ROAD 620 SUITE F184 AUSTIN TX 78717 US 78717

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-04-30