• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTILAB VENTILAB MANUAL RESUSCITATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VENTILAB VENTILAB MANUAL RESUSCITATOR Back to Search Results
Catalog Number AF1140MB
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 07/20/2017
Event Type  Injury  
Event Description
In the manual resuscitator kit there was no mask.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTILAB MANUAL RESUSCITATOR
Type of DeviceVENTILAB MANUAL RESUSCITATOR
Manufacturer (Section D)
VENTILAB
grand rapids MI 49544
MDR Report Key6735899
MDR Text Key80959489
Report NumberMW5071146
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAF1140MB
Device Lot Number308539
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

Patient Treatment Data
Date Received: 07/20/2017 Patient Sequence Number: 1
-
-