MAUDE Adverse Event Report: MERCURY MEDICAL DUAL-PURPOSE MAPLESON ANESTHESIA CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number 1080365

Device Problems Deflation Problem (1149); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2016

Event Type  malfunction  

Event Description

Patient returning from procedure.Respiratory therapist bagging intubated patient with 2l anesthesia ambu bag.Suddenly, bag deflated and noted a tear in bag.Bag attached to 3l on 02 tank with peep 10.Noted not to be hyper-inflated and with generous play of air to bag.

• Brand Name: DUAL-PURPOSE MAPLESON ANESTHESIA CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th street north; clearwater FL 33762
• MDR Report Key: 5761150
• MDR Text Key: 48512109
• Report Number: 5761150
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1080365
• Other Device ID Number: L/N 1600655810
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR