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

Model Number CPRM2226

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Affected product was not returned, investigator could not confirm or dispute claim without inspecting actual affected product.There was however; a previous claim and capa issued for product missing masks.Current claim falls within scope time frame for affected lots.

Event Description

The customer alleges that "masks are missing from the resus bag." no other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: RESUS 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 Key: 7274251
• MDR Text Key: 100458058
• Report Number: 2246980-2018-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K012842
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM2226
• Device Catalogue Number: CPRM2226
• Device Lot Number: 303716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1