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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT
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ADULT NASAL INTERFACE; BTT Back to Search Results
Model Number OPT944
Device Problems Break (1069); Disconnection (1171)
Patient Problem Low Oxygen Saturation (2477)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The subject opt944 optiflow adult nasal cannula is currently en route to fisher & paykel healthcare (f&p) (b)(6) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the opt944 optiflow adult nasal cannula disconnected after two days use.The patient was reported to have desaturated to 66% spo2 for approximately 30 seconds.It was further reported that the patient stats returned to normal once the cannula was replaced.
 
Event Description
A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow adult nasal cannula was found disconnected after 2.5 days of use.It was reported that the patient desaturated to 66% spo2 for 30 seconds.There was no further patient consequence.
 
Manufacturer Narrative
(b)(4).The opt944 interface is used to deliver humidified oxygen to patients.The opt944 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.Method: the complaint (b)(4) cannula was received at fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Result: visual inspection of complaint device revealed that the tubing of the cannula was pulled apart.Conclusion: we are unable to determine the cause of the reported event.However, the reported event is most likely caused by the tube of the (b)(4) cannula being pulled.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject cannulas would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares."; - "cannula can become unattached if not used with the head strap clip."; - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face.".The user instructions also contain the following warnings/cautions: - "do not crush or stretch tube, to prevent loss of therapy."; - "failure to use the set-up described above can compromise performance and affect patient safety.".
 
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Brand Name
ADULT NASAL INTERFACE
Type of Device
BTT
MDR Report Key10901641
MDR Text Key218923060
Report Number9611451-2020-01052
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429117
UDI-Public010942001242911710
Combination Product (y/n)N
PMA/PMN Number
K162553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT944
Device Catalogue NumberOPT944
Device Lot Number2100857058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2020
Date Manufacturer Received01/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
F&P 900PT561 HEATED BREATHING TUBE.; F&P 900PT561 HEATED BREATHING TUBE.; F&P PT101 AIRVO HUMIDIFER.; F&P PT101 AIRVO HUMIDIFER.
Patient Age86 YR
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