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U.S. Department of Health and Human Services

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

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MERCURY ENTERPRISES, INC. INFANT CPR BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
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.
 
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Brand NameINFANT CPR BAG
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
MERCURY ENTERPRISES, INC.
11300 49th st. north
clearwater FL 33762
MDR Report Key9161155
MDR Text Key161386213
Report Number9161155
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1056153
Device Lot Number1815856153
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2019
Event Location Hospital
Date Report to Manufacturer10/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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