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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED BUBBLE CPAP SYSTEM; BTT
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FISHER & PAYKEL HEALTHCARE LIMITED BUBBLE CPAP SYSTEM; BTT Back to Search Results
Model Number BC163-10
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2022
Event Type  malfunction  
Event Description
A healthcare facility in colorado reported via a fisher & paykel healthcare (f&p) field representative that a cpap probe of bubble cpap generator was loose.The bubble cpap generator is part of the bc163-10 bubble cpap system kit.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).The complaint bc163-10 is currently en route to fisher & paykel healthcare in new zealand.We will provide a follow up report once we have received the devices and completed our evaluation.
 
Manufacturer Narrative
(b)(4).Method: the complaint bc163-10 bubble cpap system was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected, and performance tested by a trained f&p technician.Result: visual inspection of the lid of the returned bubble cpap showed that it was molded.Performance testing of the returned device revealed that the distance between the probe connection was measured to be wider than that specified dimension.Conclusion: we are unable to determine the cause of the reported fault.The existing design of the cpap probe is intended to be adjustable, which leads to the possibility of inadvertent movement.We note that there is a physical stop in the bubble cpap probe, to prevent the pressure from exceeding 10cmh20, and that a pressure manifold is used with the breathing circuit, to reduce the risk of unsafe circuit pressure.The user instructions that accompany the bubble cpap system kit illustrate in pictorial format the correct set-up and proper use of the bubble cpap generator.It also states the following: "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." "regularly observe the cpap generator for bubbling.If bubbling is not observed, check for and minimize the air leaks in the system and at the patient.If air leaks have been minimized, air flow may be increased to achieve continuous bubbling.".
 
Event Description
A healthcare facility in colorado reported via a fisher & paykel healthcare (f&p) field representative that a cpap probe of bubble cpap generator was loose.The bubble cpap generator is part of the bc163-10 bubble cpap system kit.There was no patient consequence.
 
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Brand Name
BUBBLE CPAP SYSTEM
Type of Device
BTT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400, laguna canyon road
suite 300
irvine, CA 92618
9494534002
MDR Report Key15712150
MDR Text Key302845607
Report Number9611451-2022-01030
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBC163-10
Device Catalogue NumberBC163-10
Device Lot Number2102092529
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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