LIFEPAK 1000 Defibrillator Recall; Hazard Warning for Implantable Infusion Pumps
February 6, 2017 | Physician Practice News
The LIFEPAK 1000 Defibrillator manufacturer, Physio-Control, has received 34 reports of the device unexpectedly shutting down during patient treatment, an action that can put patients at risk for serious harm or death, according to Physio-Control's recall press release published by the U.S. Food and Drug Administration (FDA). The shutdown is attributed to wear and oxidation formed between the battery and device electrical contacts, which may result in the device not delivering therapy to patients during a resuscitation attempt. The company is aware of eight adverse events related to this issue, and is contacting customers and advising them to immediately remove and reinstall the battery and to continue doing so on a weekly basis until the company can provide a hardware device correction.