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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB RESUS BAG

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VENTLAB RESUS BAG Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  malfunction  
Manufacturer Narrative
The affected device was not returned for evaluation and no information was provided about product or the lot number. The customer complaint indicates that the mask in a resus system was deflated. The mask has a tail-valve that allows them to be easily re-inflated, if needed. No infomation was provided about the age of the product. The accompanying email that was received indicates that the user may have been unfamiliar with the product and did not reinfalte the mask if it was deflated.
 
Event Description
The customer alleges "the mask on resus bag is deflated. " no other details were provided and no patient injury/harm reported.
 
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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 Key6399482
MDR Text Key70034880
Report Number2246980-2017-00014
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 02/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received02/14/2017
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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