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

Catalog Number 1056153

Device Problem Defective Device (2588)

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

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Respiratory therapy department staff recognized that multiple mercury medical pediatric resuscitation masks were defective.The connector on the facemask that attaches to the resuscitation bag is misshaped leading to a problem interfacing with the bag.Multiple items in the lot reported were noted to have the same defect.Manufacturer response for respiratory, mercury medical (per site reporter).The issue was reported to mercury medical customer service and the sales representative.

• Brand Name: INFANT CPR BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): MERCURY ENTERPRISES, INC.; 11300 49th st. north; clearwater FL 33762
• MDR Report Key: 9161155
• MDR Text Key: 161386213
• Report Number: 9161155
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1056153
• Device Lot Number: 1815856153
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1