Device product
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.
Z-1458-2015
Product summary
- Event
- Event 70754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1040 units total (398 in the US and 642 international)
- Official record key
device-enforcement:Z-1458-2015
Official wording
Reason: 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.
Code information: PN: 376-0561-00.
Distribution pattern: Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.
Derived failure modes
-
Potency or specification failure
out of specification