MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT235

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Event Description

A healthcare facility in the (b)(6) reported that the inspiratory and expiratory limbs of an rt235 infant dual heated evaqua breathing circuit do not fit very well into the swivel.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint device was not available to be returned for investigation.Therefore, our investigation is based on the information provided by the hospital, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility reported that the inspiratory and expiratory limbs did not fit very well on to the swivel.A lot check could not be carried out as the lot information was not provided.Conclusion: without the return of the complaint device we are unable to determine what may have caused the problem reported by the customer.If the complaint device was returned it would have been visually inspected and the dimensions of the swivel would have been checked against the specification.All rt235 infant dual-heated evaqua breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt235 state the following: 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: INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT
• Type of Device: BZE
• 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: 4800634
• MDR Text Key: 16560449
• Report Number: 9611451-2015-00257
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K034026
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT235
• Device Catalogue Number: RT235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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