Philips Healthcare’s (NYSE:PHG) Respironics unit is in the FDA’s cross-hairs after regulators inspected a manufacturing facility responsible for infant sleep apnea monitors that were the subject of a recall.
Inspectors said that the Philips’ facility failed to properly inspect battery packs before shipping them out with the Smart Monitor 2 Apnea Monitors. The devices were found to have faulty wiring, "causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate, and oxygen saturation of infant and pediatric patients, as intended," according to the FDA’s warning letter.
The monitors were the subject of a Class II FDA recall posted last month, stemming back to Philips’ warning to customers in April. The company said that the monitors’ battery pack wire harness was improperly assembled, effectively "rendering the device inoperable."
"The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up," according to the FDA’s recall notice. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed."
The FDA’s inspection, conducted in April just a couple of weeks before Philips issued a warning to customers, cited failures in product control and monitoring that allowed non-conforming products to reach distribution. Inspectors said that Philips conducted no visual examination or functionality testing on the battery packs that were associated with the failed Smart Monitors.
The federal watchdog agency said in the formal warning letter that Philips had responded with a series of corrective actions, but that a follow-up inspection would be necessary to ensure that corrections were enacted.