Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. MEDLINE; RESUS BAG
  • 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
 

VENTLAB LLC. MEDLINE; RESUS BAG Back to Search Results
Model Number CPRM1116
Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Type  malfunction  
Manufacturer Narrative
The affected device was not returned.Visual inspection and functional testing was performed on current inventory.Out of the inventory that was evaluated two devices were found to be loose and not seating correctly, this confirmed customer claim, in which the patient valve separated at the c-ring connection.A nonconformance has been opened to further investigate this defect.
 
Event Description
The customer alleges that " elbow broke apart on the resus bag." no other details were provided and no patient injury/harm reported.
 
Manufacturer Narrative
Entered the wrong product code.The product code is btm.
 
Event Description
The customer alleges that " elbow broke apart on the resus bag." no other details were provided and no patient injury/harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDLINE
Type of Device
RESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
MDR Report Key7510563
MDR Text Key108262381
Report Number2246980-2018-00006
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K012842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCPRM1116
Device Catalogue NumberCPRM1116
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2018
Patient Sequence Number1
-
-