Melker G30488Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002304888), received between Mar 22, 2018 and Mar 22, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• DeathMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT OXYGEN COULD BE DELIVERED TO THE PATIENT THROUGH THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER, BUT IT COULD NOT BE REMOVED THROUGH THE DEVICE. THE APERTURE OF THE CATHETER WAS REPORTEDLY SO SMALL THAT VENTILATION COULD NOT BE ACHIEVED, ALTHOUGH OXYGENATION DID OCCUR BECAUSE THE AIR COULD BE FORCED IN. AUTO-PEEP (POSITIVE END EXPIRATORY PRESSURE) RESULTANTLY DEVELOPED. THE PATIENT WAS TAKEN BACK TO THE OR TO EXCHANGE THE DEVICE EMERGENTLY FOR A TRACH, BUT ULTIMATELY THE PATIENT EXPIRED. THE MANUFACTURER GLOBAL PRODUCT MANAGER HAS ATTEMPTED TO GAIN ADDITIONAL INFORMATION ON 16MAR2018 AND WAS REDIRECTED TO THE USER FACILITY RISK MANAGEMENT DEPARTMENT. THE MANUFACTURER GLOBAL PRODUCT MANAGER WAS ABLE TO SPEAK WITH THE NURSE PRESENT FOR THE PROCEDURE ON 19MAR2018, SHE DID NOT PROVIDE ADDITIONAL INFORMATION BUT HAS INDICATED SHE WOULD HAVE THE PHYSICIAN RETURN THE MANUFACTURER'S CALL. THE CUSTOMER HAS INDICATED THAT THEY ARE UNWILLING TO PROVIDE PATIENT-RELATED INFORMATION. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: Death; No Code Available

  MAUDE report 7362896 ↗