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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE Back to Search Results
Model Number RT340
Device Problems Improper Device Output (2953); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2014
Event Type  malfunction  
Manufacturer Narrative
Method: the complaint rt340 adult breathing circuit was returned to fisher & paykel healthcare (b)(6) for evaluation. The electrical resistance of the heater wires of the inspiratory and expiratory limbs was tested using a multimeter. Results: electrical resistance testing showed that the expiratory limb was within specification but that the inspiratory limb heater wire resistance was out of specification. Continuity testing and visual inspection revealed that the high resistance in the inspiratory limb heater wire was due to a poor connection between the heater wire and the connector pins. A lot check revealed that no other similar complaints have been received for lot date 140310. Conclusion: the resistance of the inspiratory limb heater wire was out of specification. This was most likely due to a poor connection between the heater wire and the connector pins that only developed after it was released for distribution. All rt340 breathing circuits are subjected to a continuity test on the production line which is followed by a resistance test and a visual inspection. Any circuits that fail are rejected. The customer has confirmed that the subject breathing circuit was in use for five days before the problem was observed, which indicates that the inspiratory limb heater wire only became out of specification after it was released for distribution.
 
Event Description
A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the temperature of an rt340 adult breathing circuit did not increase when connected to an mr850 humidifier. This was observed after five days of use. No patient consequence was reported.
 
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Brand NameADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
Type of DeviceBZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ 2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ 2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
MDR Report Key4157771
MDR Text Key12265406
Report Number9611451-2014-00808
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K983112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT340
Device Catalogue NumberRT340
Device Lot Number140310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2014
Date Manufacturer Received09/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/09/2014 Patient Sequence Number: 1
Treatment
FISHER & PAYKEL MR850 HUMIDIFIER
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