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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULMO AIDE COMPACT COMPRESSOR NEBULIZER; COMPRESSOR NEBULIZER SYSTEM
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PULMO AIDE COMPACT COMPRESSOR NEBULIZER; COMPRESSOR NEBULIZER SYSTEM Back to Search Results
Catalog Number R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Overdose (1988)
Event Date 01/31/2017
Event Type  Death  
Event Description
The death of ms.(b)(6), had full coverage with (b)(6) that covers all medical expenses.From her doctors hospital she was receiving overdose medical prescription over 50 different kinds in one month time.She was receiving 4 to 5, air pressure machines, and then went from using multiple walking canes to getting wheelchair walkers because she couldn't use walking canes no more.Four to five different wheelchair walkers, and this was over a ten year period but through all this she never got a nurse's aid or home attendant or health care aid.Her building did not have aca access no ramp or elevator and live above the first floor.The reasonable accommodation status was not granted from (b)(6) or from the building management.Dates of use: 0131 minutes.Is the product compounded: yes.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: no.Event reappeared after reintroduction: yes.No exchange after timely length.Fifty different prescriptions, 4 wheelchair walkers, 7 canes, 5 air pressure machines.All prescribed by doctor.
 
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Brand Name
PULMO AIDE COMPACT COMPRESSOR NEBULIZER
Type of Device
COMPRESSOR NEBULIZER SYSTEM
MDR Report Key6553766
MDR Text Key74820226
Report NumberMW5069624
Device Sequence Number1
Product Code CAF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 05/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberR
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other; Required Intervention; Disability;
Patient Age61 YR
Patient Weight113
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