Ventilator errors are linked to 119 deaths

Warnings are often ignored, missed by overtaxed caregivers

December 11, 2011|By Liz Kowalczyk, Globe Staff
  • Ora and Scott Davis of Quincy, with 9-year-old son Liam, who has muscular dystrophy, know firsthand how crucial alerts can be. They now have a ventilator that sets off a continuous alarm.
Ora and Scott Davis of Quincy, with 9-year-old son Liam, who has muscular… (John Tlumacki/Globe Staff )

More than a hundred patients who depend on ventilators to breathe have died since 2005 in incidents involving the machines’ warning alarms, such as caregivers failing to respond to beeps warning of a problem or setting alarms improperly so they sounded too softly or not at all.

An analysis of federal safety reports by the Globe shows that at least 119 people died nationwide between 2005 and May 2011 because of such alarm-related problems. And a separate review by the US Food and Drug Administration uncovered about 800 alarm-related adverse events involving ventilator patients in 2010 alone. Many were deemed “preventable’’ or due to “human error.’’ An unknown number resulted in injuries or deaths.

In one case last year, after a patient was moved from a hospital’s intensive care unit and connected to a new ventilator, the equipment stopped and restarted twice, triggering warnings each time.

“There appeared to be no immediate response from the staff,’’ said the report, which did not name the hospital. Someone walking by the room heard the alarm, but it was too late: The patient died.

At another hospital, a patient in the ICU became disconnected from a ventilator for unexplained reasons. The alarm went off, but nurses later said they didn’t hear it. It turned out someone had lowered the volume. That patient also died.

The FDA is so concerned about the problem that earlier this fall it issued an alert to caregivers in hospitals, nursing facilities, and patients’ homes warning that ventilator alarms are going unheard or unattended to. The agency cautioned that nurses in particular have become too dependent on the alarms in caring for patients.

The FDA’s adverse event reports analyzed by the Globe indicate that nurses and other caregivers can become desensitized to audible warnings when they hear beeps all day long, many of them false alarms. The Globe chronicled this phenomenon, called alarm fatigue, earlier this year in a series of stories about cardiac monitors used to track the condition of patients. The new data indicate that another type of critical health care technology can suffer from the same serious shortcoming.

Alarm fatigue is a significant concern for CareFusion, a leading ventilator maker, said Don Abbey, executive vice president of quality, regulatory, and medical affairs. “It’s not an easy problem to solve at this point,’’ he said.

Even family members of patients being cared for at home can tune out alarms - or fail to hear them. About one-quarter of the 119 deaths identified by the Globe occurred in patients’ homes.

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