Device product
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Z-0096-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68047
- Status
- Terminated
- Classification
- Class I
- Quantity
- US Distribution: 4,709 power supplies; Foreign Distribution: 7,425 power supplies
- Official record key
device-enforcement:Z-0096-2015
Official wording
Reason: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Code information: Desktop GemStar Power Supply List Number: 13072-05; 1) US Distribution Lot Numbers: 10115G1, 11121G1, 11122G1, 1123G1, 11124G1, 12143G1, 12144G1, 12178G1, 15185G1, 12195G1, 17214G1, 18217G1, 18219G1, 19225G1, 20233G1, 21242G1, 22251G1, 23259G1, 24271G1, 25280G1, 26289G1, 26290G1, 27293G1, 27297G1, 27300G1; 2) Foreign Distribution Lot Numbers: 11128G1, 12140G1, 12142G1, 12148G1, 14176G1, 15187G1, 15196G1, 16207G1, 16208G1, 18218G1, 19226G1, 19229G1, 20234G1, 21241G1, 22255G1, 23262G1, 24270G1, 25276G1, 26285G1, 27299G1, 27301G1
Distribution pattern: Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.