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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW; RESUS BAG
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VENTLAB LLC. AIRFLOW; RESUS BAG Back to Search Results
Model Number CPRM1126FM
Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
Suspect device was visually inspected, the device did not match the problem description the customer provided, the diaphragm on the returned part was correctly seated.The device was also checked for functionality, in which the device performed as intended.
 
Event Description
The customer alleges that "reservoir valve is faulty." no other details were provided and no patient injury/harm reported.
 
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Brand Name
AIRFLOW
Type of Device
RESUS 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 Key7048052
MDR Text Key93462700
Report Number2246980-2017-00032
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 Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCPRM1126FM
Device Lot Number310001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2017
Type of Device Usage Unknown
Patient Sequence Number1
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