• 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. STATCHECK 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. STATCHECK RESUS BAG Back to Search Results
Model Number SC9200MBP-I
Device Problem Connection Problem (2900)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
Customer reported the resuscitator bag coming apart from elbow connecting to the mask. End user did not return the affected devices for part number sc9200mbp-i,. Even though, the product was not returned, the batch record was reviewed, because end user did provide a lot number for the finished good. The batch record shows all components that go in to the finish good product. The sub-assembly patient port valve was given a closer look, this is the affected area where the end user reported the problem. The investigation team found a couple of discrepancies with a component provided by supplier. The component is part of the patient port assembly. The component discrepancy causes the patient port to not fully engage to withstand the force of mask removal.
 
Event Description
The customer alleges that " resuscitator bag coming apart from the elbow connecting to the mask" no other details were provided and no patient injury/harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTATCHECK
Type of DeviceRESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
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 Key7541453
MDR Text Key109506875
Report Number2246980-2018-00008
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC9200MBP-I
Device Lot Number313164
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 Received04/30/2018
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

-
-