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HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT (2015-10-28)
- Starting date:
- October 28, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55758
Affected Products
HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT
Reason
MAQUET Cardiopulmonary has received complaints associated with a failure of the power supply board of the HCU 30. An internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the NTC (negative temperature coefficient) R56 thermistor of the power supply board. This failure typically occurs when the compressor is switched on, i.e. before patient connection. A defective thermistor results in an inoperable compressor or in an inoperable HCU 30. There are no complaints reported associated with a patient injury or death.
Affected products
HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00705501
- 00939001
- 0704629
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY