MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.We are currently in the process of obtaining further information from the hospital.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via their distributor that an rt319 adult breathing circuit failed the initial ventilator leak test before patient use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt319 adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Our investigation is also based on our knowledge of the product, previous investigations and the information provided to us by the hospital.Results: no occlusions or holes were observed on any part of the returned breathing circuit.A lot check revealed no other complaints of this nature for lot 150520.Conclusion: we are unable to determine the cause of the reported leak on the returned breathing circuit.The hospital reported that a vented mask and exhalation adaptor was used with the complaint breathing circuit which possibly established a leak during the leak test.Based on this reported information, it is possible that the leak test failure occurred from use of a vented mask and exhalation port, as both parts have an intentional leak.If the leak test is performed with a vented mask and exhalation port, the intentional leak of one of them must be fully sealed.All rt319 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The user instructions accompanied by the rt319 adult breathing circuit state: -"before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed." -"set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported via their distributor that an rt319 adult breathing circuit failed the initial ventilator leak test before patient use.No patient consequence was reported.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• 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 ; 9194534000
• MDR Report Key: 5287882
• MDR Text Key: 33234681
• Report Number: 9611451-2015-00527
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

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: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 150520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1