Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SLEEVE, LIMB, COMPRESSIBLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SLEEVE, LIMB, COMPRESSIBLE Back to Search Results
Model Number 29525-
Medical Device Problem Code Temperature Problem (3022)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pump, s/n: (b)(4), was received.The pump could not be tested as it was received in a damaged condition and the front case was cracked.However, the power cord was received had evidence of damage and was worn out due to use overtime.The reported issue was confirmed.The service history record was reviewed, this device was manufactured in 2015 and this the first time this serial number was returned for service.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
 
Event or Problem Description
The customer reported that the device had a burnt cord and electrical smell.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SCD 700 COMPRESSION SYSTEM-US
Common Device Name
SLEEVE, LIMB, COMPRESSIBLE
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key12072756
Report Number1282497-2021-10350
Device Sequence Number4827357
Product Code JOW
UDI-Device Identifier10884521129566
UDI-Public10884521129566
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/26/2021
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 Number29525-
Device Catalogue Number29525-
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/17/2020
Initial Report FDA Received Date06/26/2021
Patient Sequence Number1
-
-