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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INSPIRATION ELITE; COMPRESSOR, AIR, PORTABLE

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RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INSPIRATION ELITE; COMPRESSOR, AIR, PORTABLE Back to Search Results
Model Number HS456
Device Problem Fire (1245)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation, so we are unable to confirm the complaint.The caregiver has, however, provided us with two photographs of the device, neither of which indicate any fire or thermal event occurred.These devices are no longer in production.
 
Event Description
It was reported that this device sparked and that there was a flame in the motor on the inside of the unit.(b)(4).
 
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Brand Name
INSPIRATION ELITE
Type of Device
COMPRESSOR, AIR, PORTABLE
Manufacturer (Section D)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
chichester business park
city fields way, tangmere
chichester, west sussex PO20 2FT
UK  PO20 2FT
Manufacturer Contact
alessandro agosti
chichester business park
city fields way, tangmere
chichester, west sussex PO20 -2FT
UK   PO20 2FT
704231549
MDR Report Key6456037
MDR Text Key71575502
Report Number9681154-2017-00005
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K042655
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2017
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 NumberHS456
Device Catalogue NumberHS456
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/07/2017
Initial Date FDA Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age8 YR
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