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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD OPTIONHOME COMPRESSOR; COMPRESSOR, AIR, PORTABLE
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RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD OPTIONHOME COMPRESSOR; COMPRESSOR, AIR, PORTABLE Back to Search Results
Model Number 1060509
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2015
Event Type  malfunction  
Event Description
It was reported that the wires of an option-home device were starting to fray.On receipt of the device there was clear indication of mains cord damage, leading to exposed wires.The evaluation concluded that the device may have been damaged by the end user, as the power cord appeared to be damaged through excessive force/abuse which caused exposed wiring.No patient harm or death has been reported.The device is not life sustaining/supporting.The user manual for this device states: "never operate this product if it has a damaged cord or plug, if it is not working properly, if it is has been dropped or damaged or dropped into water".(b)(4).
 
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Brand Name
OPTIONHOME COMPRESSOR
Type of Device
COMPRESSOR, AIR, PORTABLE
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 Key5343297
MDR Text Key35348927
Report Number9681154-2016-00001
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1060509
Device Catalogue Number1059752
Device Lot Number12M-0395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2015
Date Manufacturer Received12/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2012
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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