MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT324

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint breathing circuits caused or contributed to the reported event.We are also attempting to obtain the subject complaint devices for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in the (b)(6) reported that two rt324 infant continuous flow breathing circuits had a "split expiratory limb".This was found before patient use.

Manufacturer Narrative

(b)(4) a hospital in the (b)(6) reported that allegedly two rt324 infant continuous flow breathing circuits had a "split expiratory limb".An initial medwatch report was sent to fda on 19 october 2016.After fph had received this complaint, an fph field representative visited the hospital on 24 october 2016 to obtain further information about the reported event.It was confirmed that there was no damage to the fph rt324 circuits.An ihc600 inspire ncpap generator, containing tubing, was used in the setup and was identified as the complaint device.The ihc600 is manufactured by inspiration healthcare ltd.And is a non-fph product.The original equipment manufacturer was notified on 25 october 2016 and fph received an acknowledgement email from the oem on 25 october 2016.The oem performed a visual inspection of the received photographs of the complaint ihc600 tubing and confirmed that there was no damage to the tubing.The oem noted that the holes in the corrugated tubing are a safety feature to prevent the expiratory limb to become occluded.

Event Description

A hospital in the (b)(6) reported that allegedly two rt324 infant continuous flow breathing circuits had a "split expiratory limb".After fph had received this complaint, an fph field representative visited the hospital on 24 october 2016 to obtain further information about the reported event.It was confirmed that there was no damage to the fph rt324 circuits.There was no confirmed damage to the ihc600/10 inspire ncpap generator (manufactured by inspiration healthcare ltd., a non-fph product), which contains a tubing and was used in the setup, as well.The original equipment manufacturer was notified on 25 october 2016.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING 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 ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6039018
• MDR Text Key: 57807449
• Report Number: 9611451-2016-00676
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT324
• Device Catalogue Number: RT324
• Device Lot Number: 2100052414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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