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

Model Number RT380

Device Problems Crack (1135); Fracture (1260); Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 breathing circuit is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a distributor to an fisher & paykel healthcare (f&p) field representative that a leak alarm was generated from a servo ventilator after 2 weeks of use.A crack on the collar of the expiratory limb of the rt380 adult dual heated evaqua2 breathing circuit was identified.There was no reported patient consequence.

Event Description

A healthcare facility in japan reported via a distributor to an fisher & paykel healthcare (f&p) field representative that a leak alarm was generated from a servo ventilator after 2 weeks of use.A crack on the collar of the expiratory limb of the rt380 adult dual heated evaqua2 breathing circuit was identified.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the expiratory limb of the complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare in new zealand and was visually inspected and pressure tested.Results: visual inspection confirmed that the expiratory limb collar was cracked and the results of the pressure test were outside of specification.Conclusion: we were unable to determine conclusively what had caused the collar to crack; however, based on our previous investigations it is possible that the crack is due to being in contact with a chemical solution, resulting in environmental stress cracking.All rt380 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: - "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." - "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: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8512693
• MDR Text Key: 142231285
• Report Number: 9611451-2019-00369
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: RT380
• Device Catalogue Number: RT380
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/14/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERVO VENTILATOR; SERVO VENTILATOR