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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. AIRVO 2; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE
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FISHER & PAYKEL HEALTHCARE, INC. AIRVO 2; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE Back to Search Results
Model Number OPT970
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
Event Description
Staff rt reported that an airvo stopped working on a patient in the waiting area of ct before the ct was performed.The patient was with the rt from floor.No harm to patient.Rt placed patient on a 10-liter oxytrach mask.Patient saturating well.Airvo sequestered and taken to biomed.Rt stayed with patient and a new airvo was placed on patient after returning to floor.
 
Event Description
Staff rt reported that an airvo stopped working on a patient in the waiting area of ct before the ct was performed.The patient was with the rt from floor.No harm to patient.Rt placed patient on a 10-liter oxytrach mask.Patient saturating well.Airvo sequestered and taken to biomed.Rt stayed with patient and a new airvo was placed on patient after returning to floor.
 
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Brand Name
AIRVO 2
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE, INC.
17400 laguna canyon road
#300
irvine CA 92618
MDR Report Key16806427
MDR Text Key313916181
Report Number16806427
Device Sequence Number1
Product Code BTT
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,Followup
Report Date 03/30/2023
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 Model NumberOPT970
Device Catalogue NumberOPT970
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2023
Event Location Hospital
Date Report to Manufacturer04/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/12/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age22630 DA
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