Police defend ventilator handover

Returned the device to manufacturer after teen's death; lawyers skeptical

Fernando Vargas, 15, of East Boston died on Friday during a power outage.

Boston police and the Suffolk district attorney's office yesterday defended their decision to hand over a possibly faulty ventilator to the manufacturer and let it examine the device that shut down during a power outage and led to the death of a 15-year-old.

But lawyers who specialize in medical malpractice said they were troubled that the company, Pulmonetic Systems Inc., now could examine, without any independent overseer, the ventilator that failed Fernando Vargas of East Boston on Friday.

"If an engine fell off a plane, you certainly wouldn't just give the engine back to the manufacturer and say, 'Here, here is the engine. What do you think?' " said Michael E. Mone, a Boston lawyer who specializes in medical malpractice and product liability. "You want to be able to make sure that the evidence is preserved in such a way that [any examination] is done under observation and under protocol. You want to make sure that nothing is going to be done that would change the nature of the evidence."

Josh Wall, first assistant district attorney, said police and prosecutors gave the device to the company so trained engineers at Pulmonetic could confirm that the ventilator shut off during the power outage, and determine why.

Police have said their preliminary investigation indicates the backup battery to the ventilator failed during a two-hour power outage Friday morning.

Wall said the engineers could retrieve the information without disassembling the device, which he described as a sort of "black box" that may have recorded any alarm that went off. The company will videotape the retrieval of the data, Wall said.

"The company does have experience in obtaining this information," he said. "We have no reason to think that the company is interested in committing a crime in obstructing justice. If we had reason to think that the company would expose itself criminally to protect itself civilly we would not have taken this action."

He said the company is under federal obligation by the US Food and Drug Administration to report what went wrong with the device.

Fernando's mother, Ilia Torres, said she had not hired a lawyer but would pursue a lawsuit if she learned a mistake by the manufacturer or the contractor that supplied the device - New England Home Therapies - led to the death of her son, who was born with cerebral palsy, muscular dystrophy, and mental retardation.

"I won't do it for money," Torres said in Spanish during a telephone interview. "I will do it in the name of my son and to help other children so this can't happen to them.

"I'm going to be my son's feet. I'm going to be his voice. I'm going to fight for him until I have answers."

Torres said she found the serial number of the ventilator, a model LTV 950. She identified the number as CO6614.

That would indicate it was among more than 10,000 machines recalled by the company in 2004 because of the potential for the backup battery to fail. Models LTV 950 with serial numbers below CO7000 were among the machines recalled, according to the FDA.

Torres said police did not tell her the ventilator was going to be returned to New England Home Therapies, the contractor for the state's low-income health insurance program that supplied Vargas's ventilator, and sent to Pulmonetic.

A spokeswoman for Home Therapies, Kim Tanzer, would only say the company is conducting an internal investigation. "Our goal is to get to the bottom of what went on," she said.

A spokeswoman for Pulmonetic, Donna Gaidamak, said she could not confirm that the serial number Torres provided is accurate because the ventilator was still wrapped in its package. The shipment arrived at the company's headquarters in Minneapolis yesterday, Gaidamak said.

Company officials will not open it until the videographer, who is from an outside agency, arrives, Gaidamak said.

Every step of the company's investigation will be recorded by the videographer, including the opening of the package, she said.

"The purpose of the whole video is to document the entire process for whomever will need to see it," Gaidamak said.

The videographer is expected to arrive today or tomorrow, she said.

Marc L. Breakstone, a Boston lawyer who specializes in medical malpractice, said someone representing the family, such as a lawyer, and an independent specialist should be present when the device is examined.

"Videotape is not even half a loaf," he said. "I've just seen too many instances where vital information is not revealed and is brushed under the rug, and then you have to fight like the dickens to discover what actually happened. . . . The family desperately needs someone to be involved. They need someone on the ground to be present."

Wall said that while police and prosecutors are still investigating Vargas's death, they do not believe anyone is criminally responsible.

"However, we don't end a death investigation before it's complete," he said. "We are still obligated to follow through on the final steps. It is an additional step of the investigation to get information that is contained and recorded by the machine."

Maria Cramer can be reached at mcramer@globe.com.