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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB VENTLAB FLEX CONNECTOR; BREATHING CIRCUIT
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VENTLAB VENTLAB FLEX CONNECTOR; BREATHING CIRCUIT Back to Search Results
Catalog Number FH106380
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2015
Event Type  Injury  
Event Description
Ventlab flex connector was connected to the circuit and to the ventilator.The connector disassembled and broke apart causing the pt to be disconnected from ventilator.Hosp personnel had to replace it with another brand.
 
Manufacturer Narrative
The prod is made up of three components and designed for disassembly and re-assembly as needed.The flex connector is designed with tapered press fits that are not a locking style fit.The user may have loosened one or both of the tapered fits while adjusting or connecting.
 
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Brand Name
VENTLAB FLEX CONNECTOR
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
VENTLAB
grand rapids MI
Manufacturer Contact
2710 northridge dr nw
ste a
grand rapids, MI 49544
6162598373
MDR Report Key4612096
MDR Text Key5767255
Report Number2246980-2015-00001
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFH106380
Device Lot Number141110
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/06/2015
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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