FDA Rebukes Philips Respironics following Infant Sleep Monitor Recall

The U.S. Food and Drug Administration (FDA) is criticizing Philips Respironics, claiming that the company cut corners during the manufacturing process for its now recalled Smart Monitor 2 Apnea Monitors.

FDA Issues Warning Letter to Philips Respironics

According to MassDevice, Philips Healthcare’s Respironics division is under scrutiny following claims by FDA inspectors that the manufacturing facility responsible for producing the company’s Smart Monitor 2 infant apnea monitors failed to properly inspect battery packs before the monitors were shipped out.

In a warning letter addressed June 30, the FDA states that the recalled devices had 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.”

The warning letter also referenced an April inspection of the facility, during which inspectors noted failures in product control and monitoring and claimed that Philips had not conducted any type of visual examination or functionality testing on the monitors’ battery packs.

Within two weeks of the inspection, Philips issued a warning to consumers addressing concerns with the Smart Monitor 2 infant apnea monitor. A Class II recall was issued by the FDA in June.

Philips has responded to the warning letter with a series of corrective actions, but the FDA states that a follow-up inspection is necessary to ensure that the corrections have been enacted.

Details of the Smart Monitor 2 Recall

In their recall notice, the FDA notes that the battery pack wire harness for Philips Respironics’ Smart Monitor 2 infant apnea was assembled improperly, rending the device inoperable.

The problem can result in an error code being displayed, or the device sounding an alarm when powered on.

Serial numbers affected by the recall include:

  • 989805603611 / 1014557
  • 989805603631 / 1014559
  • 989805604511 / 1028969
  • 989805604521 / 1028970
  • 989805604531 / 1028971
  • 989805604631 / 1030271
  • 989805605051 / 1038140
  • 989805605061 / 1038141
  • 989805608801 / U1014557
  • 989805608811 / U1014559
  • 989805608831 / U1028969
  • 989805608841 / U1028970
  • 989805608851 / U1038140
  • 989805604231 / 1023384
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