MAUDE Adverse Event Report: COVIDIEN 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR; HIGH FREQUENCY VENTILATOR

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

High frequency oscillator ventilator was stopped to suction patient.When the respiratory therapist went to place patient back on ventilator, the start/stop button did not work.Alarms were set appropriately and no leak in the system was detected.The patient was bagged while a new oscillator was set up.No apparent harm to patient noted.Vital signs stable during event.Ventilator placed in dirty equipment room and red tagged for biomedical department.The circuit left on ventilator; however, blender was removed so that a backup ventilator could be set up.

• Brand Name: 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
• Type of Device: HIGH FREQUENCY VENTILATOR
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5909903
• MDR Text Key: 53331089
• Report Number: 5909903
• Device Sequence Number: 1
• Product Code: LSZ
• 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: 08/01/2016,08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Other Device ID Number: 128125
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2016
• 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 Age: 1 YR