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

Model Number RT380

Device Problems Defective Component (2292); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

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 rt380 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 that an rt380 evaqua2 adult breathing circuit was used on an intubated patient.It was reported that the orotracheal intubation probe was obstructed by an alveolar capsule (mucous plug).The patient underwent bradycardia, desaturated and an emergency reintubation was required.The hospital reported that the heater wire of the rt380 circuit was allegedly faulty.The patient's condition was reported to be stable and the patient is not intubated anymore.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 evaqua2 adult breathing circuit was not returned to fisher & paykel heatlhcare in new zealand for investigation despite multiple attempts to obtain the device.Our investigation is therefore based on our knowledge of the product and the information provided by the customer.Results: without the return of the complaint device, we are unable to confirm any fault with the complaint breathing circuit.Conclusion: all rt380 evaqua2 adult breathing circuits are subjected to a continuity test during production.Additionally, all rt380 evaqua2 adult breathing circuits are visually inspected and resistance tested prior to release for distribution.The user instructions that accompany the rt380 adult breathing circuit state the following: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms".

Event Description

A hospital in france reported that an rt380 evaqua2 adult breathing circuit was used on an intubated patient.It was reported that the orotracheal intubation probe was obstructed by an alveolar capsule (mucous plug).The patient experienced bradycardia, desaturated and emergency reintubation was required.The hospital reported that the heater wire of the rt380 circuit was allegedly faulty.The patient's condition was later reported to be stable and the patient is no longer intubated.No further patient consequence was reported.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7712691
• MDR Text Key: 114938920
• Report Number: 9611451-2018-00617
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• 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: 2100410110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; GE CARE STATION VENTILATOR; GE CARE STATION VENTILATOR
• Patient Outcome(s): Required Intervention