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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. MEDLINE RESUS BAG

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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.
 
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Brand NameMEDLINE
Type of DeviceRESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598400
MDR Report Key7510405
MDR Text Key108156034
Report Number2246980-2018-00005
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/14/2018
1 Device was Involved in the Event
0 Patients were 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
Device Model NumberCPRM1116
Device Catalogue NumberCPRM1116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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