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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB STAT CHECK MANUAL RESUSCITATOR

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VENTLAB STAT CHECK MANUAL RESUSCITATOR Back to Search Results
Model Number SC9001B
Device Problem Invalid Sensing (2293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
The customer alleges that the co2 indicator is not responding and when it does respond, the user is not sure of the accuracy. Color changes to a confusing brown. " no other details were provided and no patient injury/harm reported. Four lot numbers in inventory, all four lots were tested. In all cases, the indicators were the expected purple color when the seal was broken and the cover was removed. Each device was then exposed to co2 by breathing into them with one breath. In all of the devices, the color of the indicator changed from purple to a yellow color in approximately 8 seconds. All of the devices functioned as intended. Based on all available information, there is no indication that the device malfunctioned or was defective.
 
Event Description
The customer alleges that the co2 indicator is not responding and when it does respond, the user is not sure of the accuracy. Color changes to a confusing brown. " no other details were provided and no patient injury/harm reported.
 
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Brand NameSTAT CHECK
Type of DeviceMANUAL RESUSCITATOR
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 Key6897408
MDR Text Key87861650
Report Number2246980-2017-00024
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC9001B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2017
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 Unkown

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