MAUDE Adverse Event Report: MERCURY ENTERPRISES, INC. MERCURY MEDICAL - CHILD CPR-2 BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 10-56153

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Staff removed pediatric ambu-bag with bag-valve-mask (bvm) - mask immediately noted to be misshapen at the base which led to difficulty attaching the mask to the ambu-bag.Manufacturer response for respiratory, mercury medical - child cpr-2 bag (per site reporter).The hospital's resource management has notified the manufacturer.This writer is not aware of a response from the manufacturer at the time of this report.

• Brand Name: MERCURY MEDICAL - CHILD CPR-2 BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): MERCURY ENTERPRISES, INC.; 11300 49th street north; clearwater FL 33762
• MDR Report Key: 10975314
• MDR Text Key: 220470144
• Report Number: 10975314
• 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
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-56153
• Device Lot Number: 2001656153
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1