AMBU SPUR II
Received Jul 2, 2021 · Event occurred May 16, 2019
Report 9610691-2019-00009 · MDR key 12108039
Device
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Additional Manufacturer Narrative
THIS MDR IS RESUBMITTED AS IT WAS DISCOVERED THAT THIS MDR HAS NOT BEEN SUCCESSFULLY LOADED INTO FDAS DATABASE. THE INITIAL REPORTING TO FDA OF THIS CASE HAS BEEN DONE TO FDA WITHIN THE ORIGINAL DEADLINE, HOWEVER IN THE WRONG FILE FORMAT TO SUPPORT CORRECT UPLOAD. THIS SUBMISSION REPRESENTS A RELOAD OF DATA TO ENSURE CORRECT UPLOAD TO THE FDA DATABASE. THE SPUR II WAS RETURNED FROM CUSTOMER. THE REPORTED FAULT WAS VERIFIED, AND THE INLET VALVE DISC WAS FOUND TO HAVE COME OFF INSIDE THE INLET VALVE HOUSING. TESTING CONCLUDED THAT THE PRODUCT DID NOT FULFIL THE SPECIFICATION OF DELIVERING >85% OXYGEN CONCENTRATION IN ACCORDANCE WITH EN ISO 10651-4, PARTICULAR REQUIREMENTS FOR OPERATOR POWERED RESUSCITATORS. RESUSCITATION/VENTILATION WITH AMBIENT AIR IS STILL POSSIBLE AND WITHIN SPECIFICATIONS. TESTING HAS ALSO CONCLUDED THAT THE FAILURE CAN BE DETECTED WHEN PERFORMING THE PRESCRIBED FUNCTIONAL PRE-CHECK PER THE IFU.
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE INLET VALVE HAD COME OFF IN THE SPUR II AND WHEN USING THE PRODUCT UNDER A PROCEDURE, THE OXYGEN SATURATION OF THE PATIENT DROPPED TO 77%. THE FAULT WAS DETECTED AFTER APPROXIMATELY 45 MIN AND WAS COUNTERACTED BY USING ANOTHER OXYGEN SOURCE. THE PATIENT WAS NOT AFFECTED BY THE INCIDENT.