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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ELEGANCE; COMPRESSOR, AIR, PORTABLE
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RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ELEGANCE; COMPRESSOR, AIR, PORTABLE Back to Search Results
Model Number 1095067
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/23/2018
Type of Reportable Event Malfunction
Event or Problem Description
This device was returned without any specific fault reported.On return of the device for evaluation, it was observed that the mains cable was damaged to the extent that bare wires were visible.Based on this the patient may have been exposed to the risk of electrocution.(b)(4).
 
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Brand Name
INNOSPIRE ELEGANCE
Common Device Name
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
MDR Report Key7942367
Report Number9681154-2018-00019
Device Sequence Number770090
Product Code CAF
UDI-Device Identifier00383730001715
UDI-Public00383730001715
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K042655
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/19/2018
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
Operator of Device Other
Device Model Number1095067
Device Catalogue Number1099973
Device Lot Number170728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/19/2018
Initial Report FDA Received Date10/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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