MAUDE Adverse Event Report: VENTLAB STAT CHECK; MANUAL RESUSCITATOR

Model Number SB9001B

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

Four lot numbers of this component were found in inventory.These devic es are packaged in layers and cells with each cell containing (b)(4) pieces and each layer containing (b)(4) pieces.One hundred and thirty pieces were inspected for damage and no defects were found.The customer did not return the affected devices and the customer told our sales person that some of the broken units were broken by them pulling the product too quickly from the package and also by overtightening when breaking the seal.

Event Description

The customer alleges that the "co2 indicator is arriving broken" no other details were provided and no patient injury/harm reported.

• Brand Name: STAT CHECK
• Type of Device: MANUAL 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 Key: 6897528
• MDR Text Key: 87875469
• Report Number: 2246980-2017-00025
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SB9001B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1