MAUDE Adverse Event Report: VENTLAB, LLC / SUNMED HOLDINGS LLC AIRFLOPW SMALL ADULT RESUSCITATOR WITH MANOMETER, FILTER, MASK, BAG RESERVOIR, A; VENTILATOR, EMERGENCY MANUAL RESUSCITATOR

Model Number AF5140MBS

Device Problems Break (1069); Melted (1385); Appropriate Term/Code Not Available (3191)

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

Event Date 11/28/2018

Event Type  malfunction  

Event Description

Mask for small adult bag/mask/filter had melted / damaged connection point to bag / valve and unable to create seal.

• Brand Name: AIRFLOPW SMALL ADULT RESUSCITATOR WITH MANOMETER, FILTER, MASK, BAG RESERVOIR, A
• Type of Device: VENTILATOR, EMERGENCY MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTLAB, LLC / SUNMED HOLDINGS LLC
• MDR Report Key: 8119789
• MDR Text Key: 129194240
• Report Number: MW5081750
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: AF5140MBS
• Device Catalogue Number: AF5140MBS
• Device Lot Number: 314480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• 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