MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD REUSABLE INFANT SINGLE HEATED CIRCUIT; BTT

Model Number 900MR781

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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 900mr781 breathing circuit caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via our distributor that an 900mr781 reusable infant single heated breathing circuit failed the ventilator leak test.Additional information revealed that the circuit was damaged.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr781 reusable infant single heated breathing circuit was returned to fph in new zealand, where it was visually inspected, and a fourier transform infrared spectroscopy (ftir) and dynamic scanning calorimeter (dsc) analysis were performed.Results: visual inspection of the 900mr781 circuit revealed that there were holes in the reusable tubing.The dsc analysis revealed that the crystallinity in the complaint circuit was higher than in a control circuit and that there was very little variation of the molecular weight range between the complaint circuit and its control.Ftir analysis did not show any indication of chemical residue.Conclusion: we are unable to determine what may have caused the damage noted on the returned 900mr781 breathing circuit.All infant reusable breathing circuits are visually inspected and pressure tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported faults occurred after the subject breathing circuits were released for distribution.The user instructions that accompany the reusable infant single heated breathing circuit state: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- check all connections are firm before use.

Event Description

A hospital in (b)(6) reported via our distributor that an 900mr781 reusable infant single heated breathing circuit failed the ventilator leak test.Additional information revealed that the circuit was damaged.This was found prior to patient use.

• Brand Name: REUSABLE INFANT SINGLE 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: jonathan stevens ; 173 technology dr., suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6071922
• MDR Text Key: 59229951
• Report Number: 9611451-2016-00732
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K913368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

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: 900MR781
• Device Catalogue Number: 900MR781
• Device Lot Number: 2100035179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1