Loading MedWatcher information…
413 results
FDA · FDA event 95842
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Posted Jan 16, 2025
FDA · FDA event 95967
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting…
Posted Jan 10, 2025
FDA · FDA event 95891
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Posted Jan 8, 2025
FDA · FDA event 95848
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Posted Dec 27, 2024
FDA · FDA event 95586
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have…
Posted Nov 21, 2024
FDA · FDA event 95121
Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low…
Posted Oct 3, 2024
FDA · FDA event 94937
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Posted Sep 13, 2024
FDA · FDA event 95047
Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose…
Posted Aug 27, 2024
FDA · FDA event 94988
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the…
Posted Aug 16, 2024
FDA · FDA event 94690
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Posted Aug 9, 2024