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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. OPTIOHOME COMPRESSOR; COMPRESSOR, AIR, PORTABLE

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RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. OPTIOHOME COMPRESSOR; COMPRESSOR, AIR, PORTABLE Back to Search Results
Model Number 1059751
Device Problems Fire (1245); Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2015
Event Type  malfunction  
Event Description
The manufacturer received information alleging an optionhome compressor emitted smoke and the patient claims to have seen flames from the power cord.There was no reported patient harm during this event.(b)(4).
 
Manufacturer Narrative
Patient allegedly discarded the device and is no longer available for evaluation, therefore, this complaint cannot be verified.The device is no longer being manufactured.The device is not life sustaining/supporting.
 
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Brand Name
OPTIOHOME COMPRESSOR
Type of Device
COMPRESSOR, AIR, PORTABLE
Manufacturer (Section D)
RESPIRATORY DRUG DELIVERY GROUP (UK) LTD.
city fields way, tangmere
chichester business park
chichester, west sussex PO20 2FT
UK  PO20 2FT
Manufacturer Contact
alessandro agosti
city fields way, tangmere
chichester business park
chichester, west sussex PO20 -2FT
UK   PO20 2FT
704231549
MDR Report Key4482345
MDR Text Key5330977
Report Number9681154-2015-00001
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K924123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/01/2015
1 Device was Involved in the Event
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 Number1059751
Device Catalogue Number1059751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/01/2015
Initial Date FDA Received01/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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