MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC MEDLINE TRANSPORT CIRC PEEP W/BV-LF; CIRCUIT, BREATHING

Model Number DYNJAA300

Device Problems Display or Visual Feedback Problem (1184); No Flow (2991); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

Trauma patient had been connected to a portable ventilator for a ct scan.Immediately high pressure alarm began and no chest rise was seen.Pt removed from ventilator, manual bagging initiated, circuitry was checked.It was noted that no air was coming from the patient side of the circuit.It appeared that the one-way valve was stuck in open position.Circuit was disconnected from the vent and rt could hear air blowing.

• Brand Name: MEDLINE TRANSPORT CIRC PEEP W/BV-LF
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield IL 60093
• MDR Report Key: 8266835
• MDR Text Key: 133726216
• Report Number: 8266835
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJAA300
• Device Catalogue Number: DYNJAA300
• Device Lot Number: 18EBD610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Date Report to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1