MAUDE Adverse Event Report: CAREFUSION 211, INC.. DBA CAREFUSION VITAL SIGNS; MASK, VENTILATOR

Catalog Number 5245

Device Problems Air Leak (1008); Inflation Problem (1310)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The air cushion on the mask failed to inflate when attempting to ventilate the patient using the adult face mask (#5).Despite multiple adjustments with patient positioning, changing the long valve mask twice and changing of the jackson reese circuit, the bag simply would not inflate indicating a leak somewhere in the circuit.An ambu bag was immediately available and the patient was ventilated without issue.The trough oxygen saturation was 26% and came back up to 99% over two minutes.Upon inspection of the equipment, the mask was deflated and would not inflate with syringe; the air would simply leak out.Thus, we concluded the defective mask was the cause of not being able to obtain a seal.Several more masks of the same brand (a brand we do not regularly use as anesthesiologists; difference is with the long valve inflation mechanism) and had the same issue of not being able to inflate the mask with air.

• Brand Name: VITAL SIGNS
• Type of Device: MASK, VENTILATOR
• Manufacturer (Section D): CAREFUSION 211, INC.. DBA CAREFUSION; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 4612190
• MDR Text Key: 5697849
• Report Number: 4612190
• Device Sequence Number: 1
• Product Code: BYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 5245
• Device Lot Number: 7732982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AND CHANGING OF THE JACKSON REESE CIRCUIT, THE; NO OTHER THERAPIES; SOMEWHER IN THE CIRCUIT.; DESPITE MULTIPLE ADJUSTMENTS WITH PATIENT; POSITIONING, CHANGING THE LONG VALVE MASK TWICE; BAG SIMPLY WOULD NOT INFLATE INDICATING A LEAK
• Patient Age: 78 YR