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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE Back to Search Results
Model Number RT380
Device Problem Ventilation Problem in Device Environment (3027)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint device was recently returned to fisher & paykel healthcare in (b)(4) for evaluation. We will provide a follow up report upon completion of our investigation.
 
Event Description
A hospital in the (b)(4) reported that a patient on an rt380 adult dual-heated evaqua2 breathing circuit was unable to be ventilated. The hospital further reported that the patient was manually ventilated while they replaced the breathing circuit. No patient consequence was reported.
 
Manufacturer Narrative
(b)(4). Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected and pressure tested. Results: visual inspection of the returned circuit revealed that the filter material was discoloured and occluded. The pressure test revealed that the breathing circuit was within specification. A lot check could not be carried out as the lot information was not provided. Conclusion: based on the inspection carried out, the problem reported by the customer was most likely due to the use of an occluded filter in the set up. It is likely that the discolouration and occlusion of the filter material was the result of nebulized drugs. All rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution. Any breathing circuit which fails any of these tests is discarded. This suggests the damage noted on the filter was caused after the circuit was released for distribution. The user instructions supplied with the rt380 breathing circuit state: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. " "set appropriate ventilator alarms. " "change filter if noticeable deterioration occurs, following standard hospital procedure. " "when nebulized drugs are used resistance to flow should be monitored and the filter replaced, following standard hospital procedure. ".
 
Event Description
A hospital in the (b)(6) reported that a patient on an rt380 adult dual-heated evaqua2 breathing circuit was unable to be ventilated. The hospital further reported that the patient was manually ventilated while they replaced the breathing circuit. No patient consequence was reported.
 
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Brand NameADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of DeviceBZE
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
15365 barranca parkway
irvine, CA 92618-2216
9494534000
MDR Report Key5083268
MDR Text Key26252747
Report Number9611451-2015-00412
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K122432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/18/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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