Ambia GG16010Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675595328), received between Sep 24, 2025 and Sep 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2025Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell
IT WAS REPORTED THAT THE COLUMN OF THE ANESTHESIA PENDANT IN THE OPERATING ROOM BECAME DISCONNECTED FROM ITS SUPPORTING ARM. THE COLUMN ALONG WITH THE ATTACHED ANESTHESIA MACHINE STAND ON TO THE FLOOR. THE EVENT OCCURRED WHILE THE HEALTHCARE PERSONNEL WERE ARRANGING THE OR FOR A SCHEDULED PROCEDURE. PATIENT WAS ALREADY IN THE ROOM, BUT NOT CONNECTED YET WITH THE DEVICE. A MOBILE ANESTHESIA MACHINE WAS IMMEDIATELY PROVIDED AS A REPLACEMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130924 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.