MAUDE Adverse Event Report: VENTLAB VENTLAB; RESUSCITATION BAG

Model Number AF1140MB

Device Problems Disassembly (1168); Separation Failure (2547); Device Operates Differently Than Expected (2913)

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

Event Date 01/25/2017

Event Type  malfunction  

Event Description

Resuscitation malfunctioned- mask could not be separated from bag after several attempts.Mask-valve-assemble came apart.

• Brand Name: VENTLAB
• Type of Device: RESUSCITATION BAG
• Manufacturer (Section D): VENTLAB; grand rapids MI 49544
• MDR Report Key: 6290002
• MDR Text Key: 66317158
• Report Number: MW5067551
• Device Sequence Number: 1
• Product Code: BTM
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: AF1140MB
• Device Lot Number: 305288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR