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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UK SCD EXPRESS; SLEEVE, LIMB, COMPRESSIBLE
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COVIDIEN UK SCD EXPRESS; SLEEVE, LIMB, COMPRESSIBLE Back to Search Results
Model Number 95251S
Medical Device Problem Code Fire (1245)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/10/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported that the bending part of the power line was on fire after being plugged in.There was no injury caused by the event.
 
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Brand Name
UK SCD EXPRESS
Common Device Name
SLEEVE, LIMB, COMPRESSIBLE
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9310773
Report Number1282497-2019-08767
Device Sequence Number16771552
Product Code JOW
UDI-Device Identifier10884521129580
UDI-Public10884521129580
Combination Product (Y/N)N
Initial Reporter CountryCH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/12/2019
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 No Information
Device Model Number95251S
Device Catalogue Number95251S
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/04/2019
Initial Report FDA Received Date11/12/2019
Patient Sequence Number1
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