MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number	RT385
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt385 adult dual heated evaqua2 breathing circuit was recently received at fisher & paykel healthcare (b)(4) for evaluation.We are in the process to determine if fph's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A hospital in (b)(6) reported via a fisher and paykel healthcare (fph) field representative that the rt385 adult dual heated evaqua2 breathing circuit failed the initial ventilator leak test.The expiratory limb of the rt385 circuit was found damaged.This was found before use on a patient.There was no patient involvement.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Common Device Name: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 6613713
• Report Number: 9611451-2017-00506
• Device Sequence Number: 18917267
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2100110188(11)161125(17)211125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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
• Operator of Device: Health Professional
• Device Model Number: RT385
• Device Catalogue Number: RT385
• Device Lot Number: 2100110188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1