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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB AIRFLOW RESUS BAG

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VENTLAB AIRFLOW RESUS BAG Back to Search Results
Model Number AF5140MB
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2017
Event Type  malfunction  
Manufacturer Narrative
An extensive and thorough investigation was performed by engineering of the affected device. During the examination of the device it was observed that the exhalation port was broken off. An inventory evaluation was performed but no defects were found. The affected device was assembled in grand rapids. The device assembly process in gr production utilizes work instruction mmfg-wi-0006 for resuscitation bags. The assembly process would have identified a broken exhalation port and prevented it from making it into a finished product. It is extremely unlikely if not impossible for a broken exhalation port that was returned to have escaped the production process. The investigator's conclusion is that the affected device was most likely dropped while being used resulting in the extreme damage to the device.
 
Event Description
The customer alleges "the plastic near the bag was broken. " no other details were provided and no patient injury/harm reported.
 
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Brand NameAIRFLOW
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 Key6825140
MDR Text Key83999523
Report Number2246980-2017-00023
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
Device Lot Number306447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
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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