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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; UNKNOWN
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RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; UNKNOWN Back to Search Results
Device Problem Overheating of Device (1437)
Patient Problem Chest Tightness/Pressure (2463)
Event Date 10/19/2015
Event Type  malfunction  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
(b)(4).A patient alleged that she inhaled "smoke", that her "chest felt heavy", and required admission to an emergency room when a compressor emitted a burning odor and the ac power cord to the device "melted".There was no report of serious or permanent injury.The patient discarded the compressor and could not provide a model number, name, or serial number of the compressor.The manufacturer subsequently is unable to confirm the allegation of a thermal event.If supplemental information becomes available, the manufacturer will file a follow up report.
 
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Type of Device
UNKNOWN
Manufacturer (Section D)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
chichester business park
city fields way, tangmere
chichester, PO202 FT
UK  PO202FT
Manufacturer Contact
alessandro agosti
chichester business park city
tangmere
chichester, PO202-FT
UK   PO202FT
8704231549
MDR Report Key5239899
MDR Text Key31737983
Report Number9681154-2015-00019
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 10/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age49 YR
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