MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BUBBLE CPAP SYSTEM; BTT

Model Number BC163-10

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the bc163-10 bubble cpap system had limited pressure and the bubbler may have been leaking.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The bc163-10 bubble cpap system is designed for use with spontaneously breathing infants who require cpap therapy.The complaint bc163 breathing circuit is en route to fisher & paykel healthcare in (b)(4) for evaluation.A follow up report will be provided upon completion of our evaluation.

Manufacturer Narrative

(b)(4).The bc163-10 bubble cpap system is designed for use with spontaneously breathing infants who require cpap therapy.The complaint bc163 breathing circuit has not yet been returned to fisher & paykel healthcare in (b)(4) for evaluation.A follow up report will be provided upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the bc163-10 bubble cpap system had limited pressure and the bubbler may have been leaking.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The bc163-10 bubble cpap system is designed for use with spontaneously breathing infants who require cpap therapy.Method: the complaint bc163 breathing circuit was returned to fisher & paykel healthcare in (b)(4) and was visually inspected and leak tested.Result: no damage was observed during the visual inspection and the device worked as expected.Conclusion: no fault was found with the returned complaint device.Therefore we were unable to determine the cause of the reported event.

Event Description

A hospital in texas reported via a fisher & paykel healthcare representative that the bc163-10 bubble cpap system had limited pressure and the bubbler may have been leaking.No patient consequence was reported.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• 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 ; 9494534000
• MDR Report Key: 4521633
• MDR Text Key: 20069261
• Report Number: 9611451-2015-00082
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2015

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 Number: BC163-10
• Device Catalogue Number: BC163-10
• Device Lot Number: 140718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/15/2015; 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FPH MR850 HUMIDIFIER; FPH MR850 HUMIDIFIER