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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 Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The affected device had the exhalation port broken completely off of the manometer. The filter was still attached to the port. When this product is assembled in production, the filter is attached to the exhalation port by an operator. A broken port would not have been able to escape the production process. If the broken port was the result of a single incident such as being dropped, it must have occurred after the production process. There is the possibility that the port was cracked and a second incident caused the port to break off. An inventory inspection was performed and no cracks were found. This type of defect has not been seen before. The batch record was reviewed and there were no non-conformances.
 
Event Description
The customer alleges "the exhalation port snapped off of the bag. " 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 Key6428850
MDR Text Key70995194
Report Number2246980-2017-00015
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
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
Device Lot Number307334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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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