MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW ADULT RESUSCITATOR; VENTILATOR EMERGENCY MANUAL RESUSCITATOR

Catalog Number AF1140MB-P

Device Problems Deflation Problem (1149); Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); Missing Value Reason (3192)

Event Date 03/31/2016

Event Type  No Answer Provided  

Event Description

Deflated mask.They can add air easily, but do not have a syringe at all times.

Manufacturer Narrative

The affected resuscitator was not received for investigation, neither was a picture provided.Customer provided limited information and could not provide the lot number of the affected device.Due to limited information, it is difficult to verify the reported failure and root cause of the reported failure cannot be identified.The product is designed for trained personnel only and information for safety is provided in the ifu.The ifu states "test the resuscitator for proper function: before using the mask, inspect for adequate inflation." although the device was not returned for evaluation and no lot number was provided three different lots of this same part number were visually inspected and no deflated masks were found.

• Brand Name: AIRFLOW ADULT RESUSCITATOR
• Type of Device: VENTILATOR EMERGENCY MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5615523
• MDR Text Key: 44700931
• Report Number: 2246980-2016-00006
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AF1140MB-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Type of Device Usage: N
• Patient Sequence Number: 1