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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC.; RESUS BAG
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VENTLAB LLC.; RESUS BAG Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Fracture, Arm (2351)
Event Date 02/04/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned, no lot number or product description was reported.The customer provided two photos.One photo shows a broken stat-check elbow.The other photo presumably shows the broken piece of the stat-check elbow inside the resus bag.The broken piece appears to be contaminated with blood which presumably indicates that the device was functioning for a portion of the procedure.Without any additional information, the investigators conclusion is that the device was dropped and broken during the procedure and was not defective.Based on the available information, there is no evidence to believe that the affected device was affected.
 
Event Description
The customer alleges "elbow broke, became dislodged, obstructed the duck valve.".
 
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Type of Device
RESUS 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 Key6381604
MDR Text Key69496799
Report Number2246980-2017-00012
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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