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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREATH TECH BREATH TECH ADULT RESUSCITATOR

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BREATH TECH BREATH TECH ADULT RESUSCITATOR Back to Search Results
Model Number BT 5003
Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2017
Event Type  malfunction  
Event Description
Pt in cardiac arrest, staff reached for ambu bag that was marked adult, bag sealed from factory. Inside the bag was not an adult ambu bag, but a pediatric ambu bag.
 
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Brand NameBREATH TECH
Type of DeviceADULT RESUSCITATOR
Manufacturer (Section D)
BREATH TECH
155 boyce drive
mocksville NC 27028
MDR Report Key6659567
MDR Text Key78238898
Report NumberMW5070544
Device Sequence Number1
Product Code BTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBT 5003
Device Lot Number301861
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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