Tuesday, November 30, 2004

MINNEAPOLIS, Minn. - In response to a Sept. 8 FDA recall notice for its LTV ventilators, Pulmonetic Systems Nov. 1 began sending out adapters to correct a power problem with 10,300 units.

The company planned to send out the adapters through November and expects to resolve the issue by the end of the year.

“Those adapters can be very easily attached to the power cord of the ventilator,” said Pulmonetic CEO, Jim Hickey. “Once they are attached, they are permanently attached and that will resolve the issue.”

The problem with the ventilator is this: If the power goes out, there’s a possibility the ventilators will malfunction during the switch to the internal battery.

At Walgreens, Tim Buckley was running into just that problem. The company’s corporate director of respiratory services said his patients’ caregivers solved the power problem by manually ventilating, or ‘bagging’ the vent patient until he could get a therapist out to the house with a new machine.

“Most of our patients resist calling an ambulance because they know they’ll end up back in the hospital,” said Buckley. “[Caregivers] know what to do because we’ve had this problem with Pulmonetics before, and so we’ve done a fair amount of training so they can recognize problems.”

In the last five-and-a-half years, Pulmonetics has issued seven recalls for its ventilators.

That’s not an unusual number of recalls for a very high-tech new product,” said Hickey. “This is relatively new technology - the first time that true portability has been married with acute care ventilator technology.”

Hickey said the adapters preclude the need for suppliers to swap out the old ventilators for the new ventilators and that patients can attach the fix to the unit themselves.

Nevertheless, suppliers are frustrated, and given the history, they’re skeptical about the longevity of the fix. Apria has elected not to use the adapter for the hundreds of ventilators it has in the field. Instead, the company will pay to fix the ventilators internally.