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Recall Observatory FDA recall evidence

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

March 05, 2015

Class II

Product summary

Firm
Del Mar Reynolds Medical, Ltd.
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

    reason.potency_specification_failure · v1.0.0

    out of specification