FDA Adverse Event Malfunction Summary report: N

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

MDR report key: 3031837 · Received April 2, 2013

Report

Report Number: 9611451-2013-00230
Event Type: Malfunction
Date Received: April 2, 2013
Date of Event: March 7, 2013
Report Date: March 11, 2013
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: BZE
PMA / PMN Number: K983112
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD: THE COMPLAINT DEVICE WAS RECEIVED AND WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED A HOLE ABOUT 4.5CM FROM THE PROXIMAL CONNECTOR. THE EVAQUA LIMB APPEARED TO HAVE BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE HOW THE LIMB CAME TO BE DAMAGED. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 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; FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN MR290 CHAMBER FROM AN RT340 ADULT BREATHING CIRCUIT KIT HAD A DAMAGED WATER FEEDSET. HOWEVER, UPON EVALUATION OF THE COMPLAINT RT340 KIT, IT WAS FOUND THAT THE MR290 CHAMBER WAS WITHOUT DEFECT BUT THAT THERE WAS A HOLE IN THE EXPIRATORY LIMB OF THE BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
133908	ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT	BZE	BZE	FISHER & PAYKEL HEALTHCARE LTD	RT340

Patients

Seq	Age	Sex	Outcome	Treatment
1