FDAMarch 5, 2015device
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.
What to do
FDA enforcement status: Terminated
Brands named
del mar reynolds medicaldeldel mar
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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