This could be good news for us... Medtronics Physiocontrol suspends shipment of its defibrillators since last January 2007 according to this
news clip from Reuters:
NEW YORK, Jan 16 (Reuters) - Medtronic Inc.'s unit Physio-Control suspended the U.S. shipment of products manufactured at its Redmond, Washington plant after it identified quality system issues.
The action will delay the spin-off of Physio-Control by Medtronic and is not expected to have a material effect on Medtronic's third quarter, the medical device maker said.
The issues were identified by Physio-Control, Medtronic and the U.S. Food and Drug Administration, the company said....
According to the same news report, similar problems in the past takes "more than 12 months" to resolve. If this is true, then PhysioControl is basically out of the ballgame for at least a year! With virtually all of their products suspended for shipment due to quality problems in their manufacturing process, I wonder how this company could survive?
Meanwhile, Philips also had some quality issues with the US FDA as shown in this
news clip (also from Reuters):
WASHINGTON, Feb 27 (Reuters) - The U.S. Food and Drug Administration issued a warning letter to Philips Medical Systems about problems with the company's portable devices that shock a patient and restore a normal heart beat, according to a copy made public on Tuesday. The FDA letter, dated Jan. 29, said the unit of Philips Electronics needed to take additional corrective steps to address intermittent switch failures reported by users in FR2 and FR2+ models of automatic external defibrillators.
Although the company determined the failures were due to a manufacturing problem involving wash water contamination and recalled units from affected lots, the FDA said Philips must make changes to operating procedures that allowed the problem to occur....
I am not sure what is happening with PhysioControl and Philips at this time. Luckily for us though, our defibrillator supplier,
Zoll, is not affected in anyway with quality issues with the US FDA! Surely, Zoll will easily dominate the US market for defibrillators this year. Meanwhile, I hope we'll also be able to dominate the defibrillator market in the Philippines this year!