InHealth Technologies; Blom-Singer; Classic IN 1608-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813307011088), received between Dec 5, 2019 and Dec 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• InjuryDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE VOICE PROSTHESIS WAS INSERTED ON (B)(6) 2019 AND WAS REPORTED TO BE LEAKING ON (B)(6) 2019. THE DEVICE WAS INSPECTED BY A PHYSICIANS ASSISTANT WHO DETERMINED IT WAS FINE AND DID NOT REMOVE IT. THE PATIENT VISITED THE ER ON (B)(6) 2019 AND WAS ADMITTED TO THE HOSPITAL THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA. ALTHOUGH IT WAS INITIALLY REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH PNEUMONIA, IT WAS NOT UNTIL (B)(6) 2019 THAT INFORMATION WAS RECEIVED WHICH ALLEGED THE DEVICE CONTRIBUTED TO THE PNEUMONIA SPECIFICALLY THE PHYSICIAN'S ASSISTANT REPORTED THAT THE PATIENT HAD HIS TEP CHANGED SEVERAL TIMES DURING THE MONTH OF MAY. THE PATIENT WAS TREATED WITH BROAD-SPECTRUM ANTIBIOTICS (ZOSYN AND VANCOMYCIN). THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Pneumonia

  MAUDE report 9419237 ↗