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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINNETRONIX TYVASO INHALATION SYSTEM - NEBULIZER

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MINNETRONIX TYVASO INHALATION SYSTEM - NEBULIZER Back to Search Results
Model Number TD-100/A
Device Problems Fire (1245); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
[lower level trim] (related symptoms if any separated by commas).Smoke from device [device malfunction].Case description: this case is a spontaneous report from the united states rec'd from a consumer via a specialty pharmacy on (b)(6) 2015.The patient was a (b)(6) male of unreported height and race who first rec'd tyvaso (treprostinil) via inhalation on (b)(6) 2015 for secondary pulmonary hypertension.Inhaled (ih) treprostinil dosage was (b)(6) (3-9 breaths) four times per day at the time of the product problem.Patient initially reported one device (unk serial number) "started smoking and caught on fire." on a follow-up report submitted by the specialty pharmacy, the patient's mother further indicates that during treatment (approximately after the 8 breath) the td-100/a began to smoke.The mother does not know which device or where the smoke was coming from and further stated she could not be sure that it was not coming from the battery pack.The specialty pharmacy shipped two new devices overnight.The device with the alleged deficiency was disposed of by the patient/patient's mother.The device associated with this event was not returned for eval and it was reported that the patient discarded the device.The dhr documentation was reviewed and no evidence was found to indicate a non-conformance to the manufacturing and/or design specs.This case is submitted in the abundance of caution.Device manufacture date: 04/2014.Name and address: united states, name and address withheld.Phone #: withheld.Concomitant medical products: adcirca (tadalafil) ongoing, tyvaso (treprostinil sodium) inhalation gas, 0.6 mg/ml (b)(6) 2015 to unk.
 
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Brand Name
TYVASO INHALATION SYSTEM - NEBULIZER
Type of Device
NEBULIZER
Manufacturer (Section D)
MINNETRONIX
st. paul MN
MDR Report Key4949714
MDR Text Key16080415
Report NumberMW5044867
Device Sequence Number2
Product Code CAF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTD-100/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
Patient Weight119
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