FDA Adverse Event Malfunction Summary report: N

INOMAX DS (DELIVERY SYSTEM)

MDR report key: 1884853 · Received October 15, 2010

Report

Report Number: 3004531588-2010-00095
Event Type: Malfunction
Date Received: October 15, 2010
Date of Event: June 24, 2010
Report Date: October 15, 2010
Manufacturer: INO THERAPEUTICS LLC/IKARIA
Product Code: MRN
PMA / PMN Number: K061901
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED ERRATIC NITRIC OXIDE (NO) READINGS ON INOMAX DS (B)(4). EVAL SUMMARY: ON INVESTIGATION, WE WERE UNABLE TO DUPLICATE THE REPORTED CONDITION WITH THIS DEVICE. HOWEVER, ON EXAMINATION OF THE DEVICE SERVICE LOG, FLUCTUATING MONITORED NITRIC OXIDE (NO) VALUES WERE RECORDED. SINCE FLUCTUATING MONITORED NO VALUES HAVE BEEN OBSERVED IN THE SERVICE LOGS OF OTHER DEVICE AND HAVE BEEN LINKED TO FRETTING CORROSION OF AN INTERNAL RIBBON CABLE, THE CABLE WAS REPLACED. THE FRETTING CORROSION CAN LEAD TO INTERMITTENT HIGH RESISTANCE CONNECTION AT THE CABLE'S CONNECTOR, LEADING TO FLUCTUATING MONITORED NO VALUES. IT IS IMPORTANT TO NOTE THAT THE MONITORED NO VALUE WOULD BE FLUCTUATING IN THIS CASE AND NOT THE ACTUAL NO DELIVERED.

Description of Event or Problem · 1

ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED ERRATIC NITRIC OXIDE (NO) READINGS ON INOMAX DS (B)(4). THE RESPIRATORY THERAPIST STATES THERE WAS NO HARM TO PT AND NO ADVERSE EVENT OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO THE COMPANY FOR INVESTIGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INOMAX DS (DELIVERY SYSTEM)	APPARATUS, NITRIC OXIDE DELIVERY	MRN	INO THERAPEUTICS LLC/IKARIA	10003

Patients

Seq	Age	Sex	Outcome	Treatment
1