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

Model Number RT319

Device Problems Split (2537); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported an rt319 adult breathing circuit was 'split' and caused the humidifier to alarm.They further reported that they had opened the circuit box with a box cutter, but did not think that this had caused the observed damage.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 returned rt319 breathing circuit was visually inspected.Results: a cut was observed in the inspiratory limb.Conclusion: the position and direction of the cut indicated that the cut was caused by opening the box with a sharp object, such as a knife or boxcutter.As the customer had informed us that a boxcutter was used to open the circuit box, we can conclude that the damage was caused at this time.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 supplied with the rt319 breathing circuit state: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.

• 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: 4633755
• MDR Text Key: 5613728
• Report Number: 9611451-2015-00157
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• 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
• Report Date: 02/27/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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