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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. COMPACT INVACARE; COMPRESSOR, AIR, PORTABLE
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RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. COMPACT INVACARE; COMPRESSOR, AIR, PORTABLE Back to Search Results
Model Number IRC1710
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Information (3190)
Event Date 10/23/2014
Event Type  No Answer Provided  
Event Description
The mfr received info alleging a compact invacare compressor had been plugged into an extension cord and thereafter the pt got shocked.It is unclear at this time what the pt's condition is.The device has not yet been returned to the mfr for eval.At this time, we are unable to confirm the alleged malfunction.A follow up report will be submitted when the unit has been received and the mfr's investigation is complete.(b)(4).
 
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Brand Name
COMPACT INVACARE
Type of Device
COMPRESSOR, AIR, PORTABLE
Manufacturer (Section D)
RESPIRATORY DRUG DELIVERY GROUP (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 Key4283647
MDR Text Key5004207
Report Number9681154-2014-00033
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRC1710
Device Catalogue NumberIRC1710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/23/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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