MAUDE Adverse Event Report: MERCURY ENTERPRISES, INC.; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The pt required bagging due clinical presentation.Patient was not improving well with bagging, and when assessing to make sure everything was ok with the ambu bag, i noticed that the peep valve on the end of the bag was jammed and angled and unable to be manipulated.It was unclear whether this was a reason the patient was not improving; however, this is a safety hazard.When the ambu bag was changed, clinical presentation began improving around the same time of change.

• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): MERCURY ENTERPRISES, INC.; 11300 49th st. north; clearwater FL 33762
• MDR Report Key: 16459079
• MDR Text Key: 310430283
• Report Number: 16459079
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Female