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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PURITAN BENNETT; VENT

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COVIDIEN PURITAN BENNETT; VENT Back to Search Results
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.
 
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Brand Name
PURITAN BENNETT
Type of Device
VENT
Manufacturer (Section D)
COVIDIEN
mansfield 02048
MDR Report Key3866604
MDR Text Key4456548
Report NumberMW5036473
Device Sequence Number1
Product Code BTM
Reporter Country CodeUS
Number of Events Reported1
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 Number760
Other Device ID NumberAPPROX AGE 15 YRS
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/02/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight96
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