MAUDE Adverse Event Report: VENTLAB LLC. STATCHECK; RESUS BAG

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.

Manufacturer Narrative

The date of report should be 04-26-2018.

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.

• Brand Name: STATCHECK
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridge dr. suite a; grand rapids MI 49544
• MDR Report Key: 7541453
• MDR Text Key: 109506875
• Report Number: 2246980-2018-00008
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K982215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC9200MBP-I
• Device Lot Number: 313164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Patient Sequence Number: 1