Apr

2015

Cl II Spacelabs Pediatric Flow Sensor Kit

Company: Del Mar Reynolds Medical, Ltd.
Date of Enforcement Report: 4/29/2015
Class lI:

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.
Recall Number Z-1458-2015

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.

RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd., Hertford GB on 3/5/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1040 units total (398 in the US and 642 international)

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Spacelabs Pediatric Flow Sensor Kit

Amy Sellers

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