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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 AF5140MBP
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2017
Event Type  malfunction  
Manufacturer Narrative
The affected device was not returned for evaluation. The customer was not able to provide the actual lot number of the affected device. The lot number that was provided was from a comparable product. This comparable product was approximately 2 years old. Storage conditions for an extended period like 2 years can contribute to loss of inflation. This mask is equipped with a tail valve for quick and easy re-inflation with a syringe should more inflation be needed. There is no indication that this action was taken. Based on the information provide there is no way to know if the mask was deflated because of a defect such as a hole or tear or if there was a general loss of inflation for other reasons such as storage conditions.
 
Event Description
The customer alleges "the mask on the resus bag was deflated. " 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 LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598350
MDR Report Key6365384
MDR Text Key69015081
Report Number2246980-2017-00010
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
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 01/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MBP
Device Lot Number300254
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
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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