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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUBBLE CPAP SYSTEM; BTT

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BUBBLE CPAP SYSTEM; BTT Back to Search Results
Model Number BC161-10
Device Problems Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Ps340844.The complaint (b)(4) bubble cpap system is currently en route to fisher & paykel healthcare (b)(6) for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint bc161-10 bubble cpap system respiratory tubings were not returned to fisher & paykel healthcare in new zealand for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Conclusion: without the complaint device we are unable to confirm and determine the cause of the reported event.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected.This suggests that any damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions the accompany the flexitrunk infant nasal tubing state: "use caution when positioning the infant interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.
 
Event Description
A healthcare facility in texas reported via a fisher & paykel healthacre (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.
 
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Brand Name
BUBBLE CPAP SYSTEM
Type of Device
BTT
MDR Report Key10172176
MDR Text Key200274828
Report Number9611451-2020-00555
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K100011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/20/2020
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 Operator Health Professional
Device Model NumberBC161-10
Device Catalogue NumberBC161-10
Device Lot Number2100695472
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2020
Initial Date FDA Received06/18/2020
Supplement Dates Manufacturer Received08/28/2020
Supplement Dates FDA Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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