MAUDE Adverse Event Report: COVIDIEN PURITAN BENNETT; VENT

Model Number 760

Device Problems Device Displays Incorrect Message (2591); Output below Specifications (3004)

Patient Problem No Information (3190)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

While suctioning this pt, the rt noted the ventilator high pressure alarm sounding intermittently.After suctioning completed, ventilator alarming continued and oxygen saturations decreased to 78%.Ventilator was removed from service (sequestered) and pt was placed on a new machine and no further issues presented.(b)(4) contacted to evaluate ventilator, however, according to materials management, (b)(4) stated they would not evaluate the item due to its age and that it is not part of their fleet.A second vendor ((b)(4)) was contacted and facility is awaiting response.Biomed assessment is scheduled for monday (b)(6) 2014.

• Brand Name: PURITAN BENNETT
• Type of Device: VENT
• Manufacturer (Section D): COVIDIEN; mansfield 02048
• MDR Report Key: 3866604
• MDR Text Key: 4456548
• Report Number: MW5036473
• 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: 05/30/2014

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: Health Professional
• Device Model Number: 760
• Other Device ID Number: APPROX AGE 15 YRS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 96