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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB AAD SYSTEM
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PHILIPS RESPIRONICS I-NEB AAD SYSTEM Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem Underdose (2542)
Event Date 09/27/2016
Event Type  malfunction  
Event Description
Pt called to report that her i-neb device stopped working during her last treatment.She said it stopped once before but she tapped it on the table and it started again but this time it would not start back up.She has one more treatment to do today.I provided a missed dose consult in case it will not work again tonight.New device is being sent the fastest way we can get it to her and should get there tomorrow morning.Device had different numbers but she had a hard time reading them it looked like (b)(4).Did the reported product complaint occur while in use with a pt? yes, device stopped working during her treatment.Did the product issue cause or contribute to pt or clinical injury? unk, pt missed part of a treatment but did not report breathing issues.If yes, was any medical intervention provided? provided a missed dose consult and told the pt if her breathing became affected to go to the er.I called the pt this morning and she was able to get the device working for her last treatment of the day yesterday, and it worked this morning, so she only missed part of a treatment yesterday.She had no breathing issues.
 
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Brand Name
I-NEB AAD SYSTEM
Type of Device
I-NEB
Manufacturer (Section D)
PHILIPS RESPIRONICS
MDR Report Key6053520
MDR Text Key58411473
Report NumberMW5065559
Device Sequence Number1
Product Code CAF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID Number80830452
Is the Reporter a Health Professional? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
VENTAVIS 6 TREATMENTS QD INHALED
Patient Age57 YR
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