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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP PURITAN BENNETT 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

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COVIDIEN LP PURITAN BENNETT 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 980
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2020
Event Type  malfunction  
Event Description
Ventilator went into backup ventilation mode which runs on apnea settings.The vent posted error codes associated with inspiratory pressures.The ventilator was pulled out of service and a service call was placed to medtronic.The ventilator has 191 hours of use and was new since july 2020.
 
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Brand Name
PURITAN BENNETT 980 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key10918970
MDR Text Key218674248
Report Number10918970
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number980
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2020
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer11/30/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18980 DA
Patient Weight97
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