• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW RESUS BAG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VENTLAB LLC. AIRFLOW RESUS BAG Back to Search Results
Model Number AF5140MBP
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2016
Event Type  malfunction  
Manufacturer Narrative
An extensive and thorough investigation was performed by the engineering team that concluded the root cause for this problem is the fact that the patient port and the mask are made out of similar base materials resulting in an undesirably high coefficient of friction between the two parts. Steps have been taken to implement a material combination with a lower coefficient of friction that significantly reduces the effort required to remove the mask from the patient valve. Device not returned.
 
Event Description
The customer alleges "patient valve breaking away from the body of the bag. " no other details were provided and no patient injury/harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6289485
MDR Text Key66448553
Report Number2246980-2017-00006
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 01/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MBP
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 Received01/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-