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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB MEDLINE RESUS BAG

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VENTLAB MEDLINE RESUS BAG Back to Search Results
Model Number CPRM1116M
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 Date 09/30/2017
Event Type  malfunction  
Manufacturer Narrative
The customer alleges that there is a "faulty valve causing a leak in the resus bag" no other details were provided and no patient injury/harm reported. The customer did not return any product to be evaluated however they did provide photos. Based on the photographs, engineering can determine that the red diaphragm valve appears to be defective. Although photographic evidence is provided the photographs do not show enough detail, this makes it hard to determine the cause of the defect.
 
Event Description
The customer alleges that there is a "faulty valve causing a leak in 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
2710 northridge dr.
suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB
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 Key6986614
MDR Text Key91134685
Report Number2246980-2017-00027
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 10/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1116M
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 Received10/01/2017
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

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