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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT
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FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT Back to Search Results
Model Number OPT844
Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/20/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.The complaint opt844 nasal cannula was not returned to fisher & paykel healthcare (fph) as it had been destroyed by the hospital.The airvo humidifier used during the incident was tested by the hospital medical physics department and found to be functioning correctly, with no fault.Following notification of this incident an fph representative visited the hospital and spoke to the attending staff in order to obtain further details about the incident.We were informed that the cannula had been in use on the patient for about 10 hours prior to the incident.Staff were unable to comment on what may have caused the reported incident.They had disposed of the complaint cannula and had not noted whether it was damaged in any way.The cannula had been in use for 10 hours prior to the event, which suggests that there was no damage to the device when it was put into use.Given that the airvo humidifier had reportedly sounded a blockage alarm it is possible that the prongs had become kinked, thus occluding flow.Without the cannula to evaluate we are unable to confirm what may have caused the reported incident.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.Our user manual that accompanies the airvo humidifier instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.".
 
Event Description
A hospital in scotland reported that a patient pulled off the prongs of an opt848 adult nasal cannula and desaturated.Staff quickly put the prongs back and increased the oxygen, but the airvo2 humidifier gave a blockage alarm.The patient allegedly continued to desaturate down to 45% and required bagging.No further patient consequence was reported.
 
Manufacturer Narrative
(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.The complaint opt844 nasal cannula was not returned to fisher & paykel healthcare (fph) as it had been destroyed by the hospital.The airvo humidifier used during the incident was tested by the hospital medical physics department and found to be functioning correctly, with no fault.Following notification of this incident an fph representative visited the hospital and spoke to the attending staff in order to obtain further details about the incident.We were informed that the cannula had been in use on the patient for about 10 hours prior to the incident.Staff were unable to comment on what may have caused the reported incident.They had disposed of the complaint cannula and had not noted whether it was damaged in any way.The cannula had been in use for 10 hours prior to the event, which suggests that there was no damage to the device when it was put into use.Given that the airvo humidifier had reportedly sounded a blockage alarm it is possible that the prongs had become kinked, thus occluding flow.Without the cannula to evaluate we are unable to confirm what may have caused the reported incident.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.Our user manual that accompanies the airvo humidifier instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.".
 
Event Description
A hospital in (b)(6) reported that a patient pulled off the prongs of an opt844 adult nasal cannula and desaturated.Staff quickly put the prongs back and increased the oxygen, but the airvo2 humidifier gave a blockage alarm.The patient allegedly continued to desaturate down to 45% and required bagging.No further patient consequence was reported.
 
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Brand Name
ADULT NASAL INTERFACE
Type of Device
CAT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9194534000
MDR Report Key5012727
MDR Text Key23525534
Report Number9611451-2015-00362
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Report Date 07/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT844
Device Catalogue NumberOPT844
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age31 YR
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