MAUDE Adverse Event Report: VENTILAB VENTILAB MANUAL RESUSCITATOR

Catalog Number AF1140MB

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 07/20/2017

Event Type  Injury  

Event Description

In the manual resuscitator kit there was no mask.

• Brand Name: VENTILAB MANUAL RESUSCITATOR
• Type of Device: VENTILAB MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTILAB; grand rapids MI 49544
• MDR Report Key: 6735899
• MDR Text Key: 80959489
• Report Number: MW5071146
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AF1140MB
• Device Lot Number: 308539
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 85 YR