MAUDE Adverse Event Report: SUN MED LLC-VENT LAB VENT LAB; DEVICE, CARDIOPULMONARY RESUSCITATION

Model Number AF1002MB-P

Device Problem Bent (1059)

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

Event Date 06/09/2016

Event Type  malfunction  

Event Description

There was difficulty squeezing the ambu bag while ventilating patient.Respiratory therapy discovered white valve that open and closes inside ambu bag was bent.When new ambu bag obtained, there was no difficulty with ventilation.

• Brand Name: VENT LAB
• Type of Device: DEVICE, CARDIOPULMONARY RESUSCITATION
• Manufacturer (Section D): SUN MED LLC-VENT LAB; 2710 northridge dr. nw, suite a; grand rapids MI 49544
• MDR Report Key: 5761077
• MDR Text Key: 48511934
• Report Number: 5761077
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2016,06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AF1002MB-P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 65