InnoSpire Elegance 00 (REF 1104139)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00383730002866), received between Dec 13, 2016 and Dec 13, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2016Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE WAS NOT WORKING PROPERLY. ON RECEIPT OF THE DEVICE FOR EVALUATION THERE WAS CLEAR INDICATION OF MAINS CORD DAMAGE, LEADING TO EXPOSED WIRES. THE EVALUATION CONCLUDED THAT THE DEVICE WAS DAMAGED BY AN EXTERNAL FORCE, AS THE POWER CORD APPEARED TO BE DAMAGED THROUGH EXCESSIVE FORCE/ABUSE WHICH CAUSED EXPOSED WIRING AT SEVERAL POINTS ALONG ITS LENGTH. THE CUSTOMER HAS BEEN APPROACHED WITH REGARD TO CONFIRMING THIS ASSERTION, BUT THEY HAVE NOT PROVIDED ANY INFORMATION REGARDING HOW THE DEVICE CAME TO BE IN THIS CONDITION. THE IFU FOR THIS DEVICE CONTAINS THE WARNING'. THE POWER SUPPLY CORD CANNOT BE REPLACED BY THE USER. IN CASE THE POWER SUPPLY CORD BECOMES DAMAGED, CONTACT PHILIPS RESPIRONICS CUSTOMER SERVICE FOR REPLACEMENT (THERE IS NO SERVICE OPTION)'. NO PATIENT HARM OR DEATH HAS BEEN REPORTED AND THE DEVICE IS NOT LIFE SUSTAINING/SUPPORTING. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6168954 ↗